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1. Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study

Author

Vitale M, Vaccaro O, Masulli M, Bonora E, Del Prato S, Giorda CB, Nicolucci A, Squatrito S, AUCIELLO, STEFANIA MICHELA, Babini AC, Bani L, Buzzetti R, Cannarsa E, Cignarelli M, Cigolini M, Clemente G, Cocozza S, Corsi L, D'Angelo F, Dall'Aglio E, Di Cianni G, Fontana L, Gregori G, Grioni S, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Laviola L, Mazzucchelli C, Signorini S, Tonutti L, TREVISAN, MARCO, Zamboni C, Riccardi G, Rivellese AA, TOSCA. IT Study Group, Vitale, M, Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, C, Nicolucci, A, Squatrito, S, Auciello, S, Babini, A, Bani, L, Buzzetti, R, Cannarsa, E, Cignarelli, M, Cigolini, M, Clemente, G, Cocozza, S, Corsi, L, D'Angelo, F, Dall'Aglio, E, Di Cianni, G, Fontana, L, Gregori, G, Grioni, S, Giordano, C, Iannarelli, R, Iovine, C, Lapolla, A, Lauro, D, Laviola, L, Mazzucchelli, C, Signorini, S, Tonutti, L, Trevisan, R, Zamboni, C, Riccardi, G, Rivellese, A, Giorda, Cb, Auciello, STEFANIA MICHELA, Babini, Ac, Trevisan, Marco, Rivellese, Aa, Tosca., IT Study Group, Bonora, E, Del Prato, S, Giorda, CB, Nicolucci, A, Squatrito S, Auciello S, Babini AC, Bani L, Buzzetti R, Cannarsa E, Cignarelli M, Cigolini M, Clemente G, Cocozza S, Corsi L, D'Angelo F, Dall'Aglio E, Di Cianni G, Fontana L, Gregori G, Grioni S, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Laviola L, Mazzucchelli C, Signorini S, Tonutti L, Trevisan R, Zamboni C, Riccardi G, Rivellese AA, and TOSCA.IT Study Group

Subjects
Male, 0301 basic medicine, Physiology, Type 2 diabetes, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, Settore MED/13 - Endocrinologia, chemistry.chemical_compound, 0302 clinical medicine, Dietary polyphenols,Flavonoids,Phenolic acids,Cardiovascular risk,Type 2 diabetes,LOW-GRADE INFLAMMATION,BLOOD-PRESSURE,DIETARY POLYPHENOLS,DARK CHOCOLATE,INSULIN SENSITIVITY,RANDOMIZED-TRIALS,DISEASE,METAANALYSIS,METABOLISM,CHOLESTEROL, Risk Factors, Surveys and Questionnaires, Hydroxybenzoates, Prospective Studies, Food science, Cardiovascular risk, Dietary polyphenols, Flavonoids, Phenolic acids, education.field_of_study, Phenolic acid, Nutrition and Dietetics, biology, food and beverages, Dietary polyphenol, Middle Aged, European Prospective Investigation into Cancer and Nutrition, Cardiovascular Diseases, Female, Population, Cardiovascular risk, Dietary polyphenols, Flavonoids, Phenolic acids, Type 2 diabetes, 03 medical and health sciences, Diabetes mellitus, medicine, Humans, education, Triglycerides, Aged, 030109 nutrition & dietetics, Dose-Response Relationship, Drug, business.industry, Cholesterol, HDL, C-reactive protein, Polyphenols, Cholesterol, LDL, Anthropometry, medicine.disease, Diet, Cross-Sectional Studies, Nutrition Assessment, Diabetes Mellitus, Type 2, chemistry, Flavonoid, biology.protein, Glycated hemoglobin, business, Body mass index
Abstract

Background: The role of polyphenol intake on cardiovascular risk factors is little explored, particularly in people with diabetes. Aim: To evaluate the association between the intake of total polyphenols and polyphenol classes with the major cardiovascular risk factors in a population with type 2 diabetes. Methods: Dietary habits were investigated in 2573 males and females participants of the TOSCA.IT study. The European Prospective Investigation on Cancer and Nutrition (EPIC) questionnaire was used to assess dietary habits. In all participants, among others, we assessed anthropometry, plasma lipids, blood pressure, C-reactive protein and HbA1c following a standard protocol. The USDA and Phenol-Explorer databases were used to estimate the polyphenol content of the habitual diet. Results: Average intake of polyphenols was 683.3 ± 5.8 mg/day. Flavonoids and phenolic acids were the predominant classes (47.5% and 47.4%, respectively). After adjusting for potential confounders, people with the highest intake of energy-adjusted polyphenols (upper tertile) had a more favorable cardiovascular risk factors profile as compared to people with the lowest intake (lower tertile) (BMI was 30.7 vs 29.9 kg/m2, HDL-cholesterol was 45.1 vs 46.9 mg/dl, LDL-cholesterol was 103.2 vs 102.1 mg/dl, triglycerides were 153.4 vs 148.0 mg/dl, systolic and diastolic blood pressure were respectively 135.3 vs 134.3 and 80.5 vs 79.6 mm/Hg, HbA1c was 7.70 vs 7.67%, and C-reactive Protein was 1.29 vs 1.25 mg/dl, p < .001 for all). The findings were very similar when the analysis was conducted separately for flavonoids or phenolic acids, the two main classes of polyphenols consumed in this population. Conclusions: Polyphenol intake is associated with a more favorable cardiovascular risk factors profile, independent of major confounders. These findings support the consumption of foods and beverages rich in different classes of polyphenols particularly in people with diabetes. Clinical trial: . http://www.clinicaltrials.gov; Study ID number: . NCT00700856. © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism.

Published
2017
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2. Consensus on: Screening and therapy of coronary heart disease in diabetic patients

Author

Rivellese AA1, Piatti PM, Italian Intersociety Consensus G.r.o.u.p. Collaborators Piatti PM, Avogaro A, Anfossi G, Ardigo D, de Kreutzenberg SV, Inchiostro S, Rivellese AA, Trovati M, Zambon S, Zavaroni I, Arcangeli A, Lettino M, Mafrici A, Uguccioni M, Bianchi A, Cavallaro V, Monducci I, Cadeddu C, De Luca G, Manzato E., GENTILE, Sandro, Rivellese, ANGELA ALBAROSA, P. M., Piatti, Rivellese, Aa1, Piatti, Pm, Collaborators Piatti PM, Italian Intersociety Consensus G. r. o. u. p., Avogaro, A, Anfossi, G, Ardigo, D, de Kreutzenberg, Sv, Inchiostro, S, Rivellese, Aa, Trovati, M, Zambon, S, Zavaroni, I, Arcangeli, A, Gentile, Sandro, Lettino, M, Mafrici, A, Uguccioni, M, Bianchi, A, Cavallaro, V, Monducci, I, Cadeddu, C, De Luca, G, and Manzato, E.

Subjects
medicine.medical_specialty, Diabetic Cardiomyopathies, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Cardiovascular risk factors, MEDLINE, Coronary heart disease, Diabetes, Cardiovascular risk factors, Medicine (miscellaneous), Coronary Disease, Revascularization, Electrocardiography, Risk Factors, Diabetes mellitus, Myocardial Revascularization, medicine, Humans, Hypoglycemic Agents, Intensive care medicine, Antihypertensive Agents, Hypolipidemic Agents, Nutrition and Dietetics, Framingham Risk Score, medicine.diagnostic_test, business.industry, Diabetes, Evidence-based medicine, medicine.disease, Coronary heart disease, Italy, Echocardiography, Physical therapy, Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors
Abstract

The screening and best treatment for coronary heart disease in diabetic patients is still a matter of debate. For this reason the main Italian scientific societies dealing with diabetes and cardiovascular diseases have tried to finalize a document providing shared recommendations based on the available evidence on : 1) how and who to screen for coronary heart disease, 2) methodologies for the characterization of existing coronary heart disease 3) evaluation of the optimal treatment of cardiovascular risk factors and 4) appropriate revascularization procedures. For each of these points, the levels of evidence and strength of recommendations used in the Italian Standard of Care were adopted.

Published
2011
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3. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Author

Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, Ap, Rivellese, Aa, Squatrito, S, Giorda, Cb, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, Ac, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, Ac, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, IT) study group, Thiazolidinediones Or Sulfonylureas Cardiovascular Accidents Intervention Trial (TOSCA., Collaborators: Vaccaro O, Italian Diabetes Society., D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Corsi, A, Dodesini, Ar, Reggiani, Gm, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi MS, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, Mr, Franzetti, I, Radin, R, Annunziata, F, Bonabello, La, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, Mpa, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta GG, De Gregorio, A, D'Andrea, S, Giuliani, Ae, Polidoro, Wl, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, Ml, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, Mc, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, Pm, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, Gv, Loi, C, Oldani, M, Bottalico, Ml, Pellegata, B, Bonomo, M, Menicatti, Lsm, Resi, V, Bertuzzi, F, Disoteo, Eo, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, Sm, Turco, Aa, Costagliola, L, Corte, Gd, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, Nc, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Babini, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, Ks, Penno, G, Livraga, S, Calzoni, F, Mancastroppa, Glf, Corsini, E, Tedeschi, A, Gaglianò, Ms, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Di Bartolo, P, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, Me, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, Ap, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, Pc, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, Ml, Coletti, Mf, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, Ce, Agrusta, M., Vaccaro, Olga, Masulli, Maria, Nicolucci, Antonio, Bonora, Enzo, Del Prato, Stefano, Maggioni, Aldo P, Rivellese, Angela A, Squatrito, Sebastiano, Giorda, Carlo B, Sesti, Giorgio, Mocarelli, Paolo, Lucisano, Giuseppe, Sacco, Michele, Signorini, Stefano, Cappellini, Fabrizio, Perriello, Gabriele, Babini, Anna Carla, Lapolla, Annunziata, Gregori, Giovanna, Giordano, Carla, Corsi, Laura, Buzzetti, Raffaella, Clemente, Gennaro, Di Cianni, Graziano, Iannarelli, Rossella, Cordera, Renzo, La Macchia, Olga, Zamboni, Chiara, Scaranna, Cristiana, Boemi, Massimo, Iovine, Ciro, Lauro, Davide, Leotta, Sergio, Dall'Aglio, Elisabetta, Cannarsa, Emanuela, Tonutti, Laura, Pugliese, Giuseppe, Bossi, Antonio C, Anichini, Roberto, Dotta, Francesco, Di Benedetto, Antonino, Citro, Giuseppe, Antenucci, Daniela, Ricci, Lucia, Giorgino, Francesco, Santini, Costanza, Gnasso, Agostino, De Cosmo, Salvatore, Zavaroni, Donatella, Vedovato, Monica, Consoli, Agostino, Calabrese, Maria, Di Bartolo, Paolo, Fornengo, Paolo, Riccardi, Gabriele, Maggioni, Aldo Pietro, D'Angelo, Federica, Giansanti, Roberto, Tanase, Laura, Lanari, Luigi, Testa, Ivano, Pancani, Francesca, Ranchelli, Anna, Vagheggi, Paolo, Scatona, Alessia, Fontana, Lucia, Laviola, Luigi, Tarantino, Lucia, Ippolito, Claudia, Gigantelli, Vittoria, Manicone, Mariangela, Conte, Eleonora, Trevisan, Roberto, Rota, Rossella, Corsi, Anna, Dodesini, Alessandro R., Reggiani, Giulio Marchesini, Montesi, Luca, Mazzella, Natalia, Forlani, Gabriele, Caselli, Chiara, Di Luzio, Raffaella, Mazzotti, Arianna, Aiello, Antimo, Barrea, Angelina, Musto, Antonio, D'Amico, Fiorentina, Sinagra, Tiziana, Longhitano, Sara, Trowpea, Vanessa, Sparti, Maria, Italia, Salvatore, Lisi, Enrico, Grasso, Giuseppe, Pezzino, Vincenzo, Insalaco, Federica, Carallo, Claudio, Scicchitano, Caterina, De Franceschi, Maria Serena, Calbucci, Giovanni, Ripani, Raffaella, Cuneo, Giacomo, Corsi, Simona, Giorda, Carlo B., Romeo, Francesco, Lesina, Annalisa, Comoglio, Marco, Bonetto, Caterina, Robusto, Anna, Nada, Elisa, Asprino, Vincenzo, Cetraro, Rosa, Impieri, Michelina, Lucchese, Giuseppe, Donnarumma, Giovanna, Tizio, Biagio, Lenza, Lazzaro, Paraggio, Pia, Tomasi, Franco, Dozio, Nicoletta, Scalambra, Egle, Mannucci, Edoardo, Lamanna, Caterina, Cignarelli, Mauro, Macchia, Olga La, Fariello, Stefania, Sorrentino, Maria Rosaria, Franzetti, Ivano, Radin, Raffaella, Annunziata, Francesca, Bonabello, Laura Affinito, Durante, Arianna, Dolcino, Mara, Gallo, Fiorenza, Mazzucchelli, Chiara, Aleo, Anna, Melga, Pierluigi, Briatore, Lucia, Maggi, Davide, Storace, Daniela, Cecoli, Francesca, D'Ugo, Ercole, Pupillo, Mario, Baldassarre, Maria Pompea Antonia, Salvati, Filippo, Minnucci, Anita, De Luca, Angelo, Zugaro, Antonella, Santarelli, Livia, Bosco, Angela, Petrella, Vittorio, La Verghetta, Grazia Giovanna, De Gregorio, Antonella, D'Andrea, Settimio, Giuliani, Anna Elisa, Polidoro, W. Lorella, Sperandio, Alessandra, Sciarretta, Filomena, Pezzella, Alfonso, Carlone, Angela, Potenziani, Stella, Venditti, Chiara, Foffi, Chiara, Carbone, Salvatore, Cipolloni, Laura, Moretti, Chiara, Leto, Gaetano, Serra, Rosalia, Petrachi, Francesca, Romano, Isabella, Lacaria, Emilia, Russo, Laura, Goretti, Chiara, Sannino, Claudia, Dolci, Maria, Bruselli, Laura, Mori, Mary L., Baccetti, Fabio, Del Freo, Maria, Cucinotta, Domenico, Giunta, Loretta, Ruffo, Maria Concetta, Cannizzaro, Desiree, Pintaudi, Basilio, Perrone, Giovanni, Pata, Pietro, Ragonese, Francesco, Lettina, Gabriele, Mancuso, Teresa, Coppolino, Aldo, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Lucotti, Pietro, Setola, Manuela, Crippa, Giulia Valentina, Loi, Cinzia, Oldani, Matteo, Bottalico, Maria Luisa, Pellegata, Beatrice, Bonomo, Matteo, Menicatti, Laura Silvia Maria, Resi, Veronica, Bertuzzi, Federico, Disoteo, Eugenia Olga, Pizzi, Gianluigi, Rivellese, Angela Albarosa, Annuzzi, Giovanni, Capaldo, Brunella, Nappo, Rossella, Auciello, Stefania Michela, Turco, Anna Amelia, Costagliola, Lucia, Corte, Giuseppina Della, Vallefuoco, Pasquale, Nappi, Francesca, Vitale, Marilena, Cocozza, Sara, Ciano, Ornella, Massimino, Elena, Garofalo, Nadia, Avogaro, Angelo, Guarneri, Gabriella, Fedele, Domenico, Sartor, Giovanni, Chilelli, Nino Cristiano, Burlina, Silvia, Bonsembiante, Barbara, Galluzzo, Aldo, Torregrossa, Vittoria, Mancastroppa, Giovanni, Arsenio, Leone, Cioni, Federico, Caronna, Silvana, Papi, Matteo, Babini, Massimiliano, Santeusanio, Fausto, Calagreti, Gioia, Timi, Alessia, Tantucci, Alice, Marino, Cecilia, Ginestra, Federica, Di Biagio, Rosamaria, Taraborelli, Merilda, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Politi, Konstantina Savina, Penno, Giuseppe, Livraga, Stefania, Calzoni, Fabio, Mancastroppa, Giovanni Luigi Francesco, Corsini, Elisa, Tedeschi, Anna, Gaglianã², Maria Sole, Ippolito, Giulio, Salutini, Elisabetta, Cervellino, Francesco, Natale, Maria, Salvatore, Vita, Zampino, Armando, Sinisi, Rosa, Arcangeli, Adolfo, Zogheri, Alessia, Guizzotti, Sandra, Longo, Rossella, Pellicano, Francesca, Scolozzi, Patrizia, Termine, Simona, Luberto, Alessandra, Ballardini, Giorgio, Trojani, Cristina, Mazzuca, Paolo, Bruglia, Matteo, Ciamei, Monica, Genghini, Silvia, Zannoni, Chiara, Vitale, Martina, Rangel, Graziela, Salvi, Laura, Zappaterreno, Alessandra, Cordone, Samantha, Simonelli, Paola, Meggiorini, Marilla, Frasheri, Aurora, Di Pippo, Clelia, Maglio, Cristina, Mazzitelli, Giulia, Rinaldi, Maria Elena, Galli, Angelica, Romano, Maria, D'Angelo, Paola, Suraci, Concetta, Bacci, Simonetta, Palena, Antonio Pio, Genovese, Stefano, Mancino, Monica, Rondinelli, Maurizio, Capone, Filippo, Calabretto, Elisabetta, Bulgheroni, Monica, Bucciarelli, Loredana, Ceccarelli, Elena, Fondelli, Cecilia, Santacroce, Clorinda, Guarino, Elisa, Nigi, Laura, Lalli, Carlo, Di Vizia, Giovanni, Scarponi, Maura, Montani, Valeria, Di Bernardino, Paolo, Romagni, Paola, Dolcetti, Katia, Forte, Elisa, Tamburo, Lucilla, Perin, Paolo Cavallo, Prinzis, Tania, Gruden, Gabriella, Bruno, Graziella, Zucco, Chiara, Perotta, Massimo, Marena, Saverio, Monsignore, Simona, Panero, Francesco, Ponzi, Fulvia, Bossi, Antonio Carlo, Carpinteri, Rita, Casagrande, Maria Linda, Coletti, Maria Francesca, Balini, Annalisa, Filopanti, Marcello, Madaschi, Sara, Pulcina, Anna, Grimaldi, Franco, Venturini, Giorgio, Agus, Sandra, Pagnutti, Stefania, Guidotti, Francesca, Cavarape, Alessandro, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Fainelli, Giulia, Tomasetto, Elena, Zoppini, Giacomo, Galletti, Anna, Perrone, Dominica, Capra, Claudio, Bianchini, Francesca, Ceseri, Martina, Di Nardo, Barbara, Sasso, Elisa, Bartolomei, Barbara, Suliman, Irina, Fabbri, Gianna, Romano, Geremia, Maturo, Nicola, Nunziata, Giuseppe, Capobianco, Giuseppe, De Simone, Giuseppina, Villa, Valeria, Rota, Giuseppe, Pentangelo, Carmine, Carbonara, Ornella, Caiazzo, Gennaro, Cutolo, Michele, Sorrentino, Tommasina, Mastrilli, Valeria, Amelia, Umberto, Masi, Stefano, Corigliano, Gerardo, Gaeta, Iole, Armentano, Vincenzo, Calatola, Pasqualino, Capuano, Gelsomina, Angiulli, Bruno, Auletta, Pasquale, Petraroli, Ettore, Iodice, Cinzia E., Agrusta, Mariano, Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, di Bartolo, Paolo, Polidoro, w Lorella, Sartore, Giovanni, and Gaglianò, Maria Sole

Subjects
Male, Diabetes and Metabolism, ipoglycemic drugs, cardiovascualr event, Settore MED/09 - Medicina Interna, endocrine system diseases, IMPACT, pioglitazone versus sulfonylureas, Endocrinology, Diabetes and Metabolism, GLIMEPIRIDE, Diabetes, cardiovascular events, metformin, pioglitazone, sulphonylureas, Type 2 diabetes, 030204 cardiovascular system & hematology, Internal Medicine, Endocrinology, law.invention, Settore MED/13 - Endocrinologia, Glibenclamide, 0302 clinical medicine, Randomized controlled trial, law, GLYCEMIC CONTROL, Gliclazide, Internal medicine, diabetes and metabolism, RISK, education.field_of_study, diabetes, Incidence, endocrinology, diabetes and metabolism, endocrinology, Middle Aged, INSULIN, Metformin, Treatment Outcome, Editorial, sulphonylureas, Cardiovascular Diseases, Combination, Drug Therapy, Combination, Female, Type 2, medicine.drug, medicine.medical_specialty, Population, 030209 endocrinology & metabolism, Aged, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Pioglitazone, Sulfonylurea Compounds, Thiazolidinediones, Cardiovascular events, 03 medical and health sciences, GLUCOSE-LOWERING DRUGS, Drug Therapy, Diabetes Mellitus, medicine, sulfonylureas, education, TOSCA.IT, business.industry, MORTALITY, nutritional and metabolic diseases, Insulin resistance, medicine.disease, Surgery, Glimepiride, business, FOLLOW-UP
Abstract

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50–75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2–3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15–45 mg) or a sulfonylurea (5–15 mg glibenclamide, 2–6 mg glimepiride, or 30–120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-years) who were given sulfonylureas (hazard ratio 0·96, 95% CI 0·74–1·26, p=0·79). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p

Published
2017
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4. Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial

Author

Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, IT study group, T. O. S. C. A., Sud, Cm, Imbaro, S, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, S, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, G, Rizzo, Mr, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, Francesco, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini, M., Vaccaro, O1, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, Collaborators Riccardi G, T. O. S. C. A. IT study g. r. o. u. p., Sud, Cm, Imbaro, S, Vaccaro, O, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, Sandro, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, Giuseppe, Rizzo, Maria Rosaria, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, F, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini M., Author information, Vaccaro, Olga, Masulli, Maria, Rivellese, ANGELA ALBAROSA, Riccardi, Gabriele, Giorda, C, Maggioni, A, Rivellese, A, Giorda, CB, Maggioni, AP, and Rivellese, AA

Subjects
Blood Glucose, Male, BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA, Endocrinology, Diabetes and Metabolism, pioglitazone, sulfonylurea, type 2 diabetes, metformin, cardiovascular events, Medicine (miscellaneous), Type 2 diabetes, Settore MED/13 - Endocrinologia, Body Mass Index, law.invention, Randomized controlled trial, Risk Factors, law, Surveys and Questionnaires, Cardiovascular Disease, pioglitazone, piogllitazone, Stroke, Diabetes, Therapy, Pioglitazone, Nutrition and Dietetics, Diabetes, Thiazolidinedione, cardiovascular events, Type 2 Diabetes Mellitus, sulphonylureas, Middle Aged, Metformin, Sulfonylurea Compound, Treatment Outcome, Tolerability, Cardiovascular Diseases, Drug Therapy, Combination, Female, type 2 diabetes, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Endpoint Determination, sulfonylurea, cardiovascualr event, Sudden death, Follow-Up Studie, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, sulfonylureas, interventio trial, randomized controlled trial, Aged, Hypoglycemic Agent, Questionnaire, business.industry, Risk Factor, medicine.disease, Surgery, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Quality of Life, Thiazolidinediones, Therapy, business, metformin, Pioglitazone, Follow-Up Studies
Abstract

Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50–75 years, BMI 20–45 Kg/m 2 , on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. Conclusions TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials.gov ID NCT00700856.

Published
2012

5. Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study

Author

Vitale, M, Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, C, Nicolucci, A, Squatrito, S, Auciello, S, Babini, A, Bani, L, Buzzetti, R, Cannarsa, E, Cignarelli, M, Cigolini, M, Clemente, G, Cocozza, S, Corsi, L, D'Angelo, F, Dall'Aglio, E, Di Cianni, G, Fontana, L, Gregori, G, Grioni, S, Giordano, C, Iannarelli, R, Iovine, C, Lapolla, A, Lauro, D, Laviola, L, Mazzucchelli, C, Signorini, S, Tonutti, L, Trevisan, R, Zamboni, C, Riccardi, G, Rivellese, A, Vitale M, Vaccaro O, Masulli Maria, Bonora E, Del Prato S, Giorda CB, Nicolucci A, Squatrito S, Auciello S, Babini A, Bani L, Buzzetti R, Cannarsa E, Cignarelli M, Cigolini M, Clemente G, Cocozza S, Corsi L, D'Angelo F, Dall'Aglio E, Di Cianni G, Fontana L, Gregori G, Grioni S, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Laviola L, Mazzucchelli C, Signorini S, Tonutti L, Trevisan R, Zamboni C, Riccardi G, Rivellese AA, Vitale, M, Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, C, Nicolucci, A, Squatrito, S, Auciello, S, Babini, A, Bani, L, Buzzetti, R, Cannarsa, E, Cignarelli, M, Cigolini, M, Clemente, G, Cocozza, S, Corsi, L, D'Angelo, F, Dall'Aglio, E, Di Cianni, G, Fontana, L, Gregori, G, Grioni, S, Giordano, C, Iannarelli, R, Iovine, C, Lapolla, A, Lauro, D, Laviola, L, Mazzucchelli, C, Signorini, S, Tonutti, L, Trevisan, R, Zamboni, C, Riccardi, G, Rivellese, A, Vitale M, Vaccaro O, Masulli Maria, Bonora E, Del Prato S, Giorda CB, Nicolucci A, Squatrito S, Auciello S, Babini A, Bani L, Buzzetti R, Cannarsa E, Cignarelli M, Cigolini M, Clemente G, Cocozza S, Corsi L, D'Angelo F, Dall'Aglio E, Di Cianni G, Fontana L, Gregori G, Grioni S, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Laviola L, Mazzucchelli C, Signorini S, Tonutti L, Trevisan R, Zamboni C, Riccardi G, and Rivellese AA

Abstract

Background: The role of polyphenol intake on cardiovascular risk factors is little explored, particularly in people with diabetes. Aim: To evaluate the association between the intake of total polyphenols and polyphenol classes with the major cardiovascular risk factors in a population with type 2 diabetes. Methods: Dietary habits were investigated in 2573 males and females participants of the TOSCA.IT study. The European Prospective Investigation on Cancer and Nutrition (EPIC) questionnaire was used to assess dietary habits. In all participants, among others, we assessed anthropometry, plasma lipids, blood pressure, C-reactive protein and HbA1c following a standard protocol. The USDA and Phenol-Explorer databases were used to estimate the polyphenol content of the habitual diet. Results: Average intake of polyphenols was 683.3 ± 5.8 mg/day. Flavonoids and phenolic acids were the predominant classes (47.5% and 47.4%, respectively). After adjusting for potential confounders, people with the highest intake of energy-adjusted polyphenols (upper tertile) had a more favorable cardiovascular risk factors profile as compared to people with the lowest intake (lower tertile) (BMI was 30.7 vs 29.9 kg/m2, HDL-cholesterol was 45.1 vs 46.9 mg/dl, LDL-cholesterol was 103.2 vs 102.1 mg/dl, triglycerides were 153.4 vs 148.0 mg/dl, systolic and diastolic blood pressure were respectively 135.3 vs 134.3 and 80.5 vs 79.6 mm/Hg, HbA1c was 7.70 vs 7.67%, and C-reactive Protein was 1.29 vs 1.25 mg/dl, p <.001 for all). The findings were very similar when the analysis was conducted separately for flavonoids or phenolic acids, the two main classes of polyphenols consumed in this population. Conclusions: Polyphenol intake is associated with a more favorable cardiovascular risk factors profile, independent of major confounders. These findings support the consumption of foods and beverages rich in different classes of polyphenols particularly in people with diabetes. Clinical trial: http://w

Published
2017

6. Influence of dietary fat and carbohydrates proportions on plasma lipids, glucose control and low-grade inflammation in patients with type 2 diabetes—The TOSCA.IT Study

Author

Vitale, M, Masulli, M, Rivellese, A, Babini, A, Boemi, M, Bonora, E, Buzzetti, R, Ciano, O, Cignarelli, M, Cigolini, M, Clemente, G, Citro, G, Corsi, L, Dall'Aglio, E, Del Prato, S, Di Cianni, G, Dolci, M, Giordano, C, Iannarelli, R, Iovine, C, Lapolla, A, Lauro, D, Leotta, S, Mazzucchelli, C, Montani, V, Perriello, G, Romano, G, Romeo, F, Santarelli, L, di Cola, R, Squatrito, S, Tonutti, L, Trevisan, R, Turco, A, Zamboni, C, Riccardi, G, Vaccaro, O, Vitale M, Masulli M, Rivellese AA, Babini AC, Boemi M, Bonora E, Buzzetti R, Ciano O, Cignarelli M, Cigolini M, Clemente G, Citro G, Corsi L, Dall'Aglio E, Del Prato S, Di Cianni G, Dolci MA, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Leotta S, Mazzucchelli C, Montani V, Perriello G, Romano G, Romeo F, Santarelli L, di Cola RS, Squatrito S, Tonutti L, Trevisan R, Turco AA, Zamboni C, Riccardi G, Vaccaro O, Vitale, M, Masulli, M, Rivellese, A, Babini, A, Boemi, M, Bonora, E, Buzzetti, R, Ciano, O, Cignarelli, M, Cigolini, M, Clemente, G, Citro, G, Corsi, L, Dall'Aglio, E, Del Prato, S, Di Cianni, G, Dolci, M, Giordano, C, Iannarelli, R, Iovine, C, Lapolla, A, Lauro, D, Leotta, S, Mazzucchelli, C, Montani, V, Perriello, G, Romano, G, Romeo, F, Santarelli, L, di Cola, R, Squatrito, S, Tonutti, L, Trevisan, R, Turco, A, Zamboni, C, Riccardi, G, Vaccaro, O, Vitale M, Masulli M, Rivellese AA, Babini AC, Boemi M, Bonora E, Buzzetti R, Ciano O, Cignarelli M, Cigolini M, Clemente G, Citro G, Corsi L, Dall'Aglio E, Del Prato S, Di Cianni G, Dolci MA, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Leotta S, Mazzucchelli C, Montani V, Perriello G, Romano G, Romeo F, Santarelli L, di Cola RS, Squatrito S, Tonutti L, Trevisan R, Turco AA, Zamboni C, Riccardi G, and Vaccaro O

Abstract

Purpose: The optimal macronutrient composition of the diet for the management of type 2 diabetes is debated, particularly with regard to the ideal proportion of fat and carbohydrates. The aim of the study was to explore the association of different proportions of fat and carbohydrates of the diet—within the ranges recommended by different guidelines—with metabolic risk factors. Methods: We studied 1785 people with type 2 diabetes, aged 50–75, enrolled in the TOSCA.IT Study. Dietary habits were assessed using a validated food-frequency questionnaire (EPIC). Anthropometry, fasting lipids, HbA1c and C-reactive protein (CRP) were measured. Results: Increasing fat intake from <25 to ≥35 % is associated with a significant increase in LDL-cholesterol, triglycerides, HbA1c and CRP (p < 0.05). Increasing carbohydrates intake from <45 to ≥60 % is associated with significantly lower triglycerides, HbA1c and CRP (p < 0.05). A fiber intake ≥15 g/1000 kcal is associated with a better plasma lipids profile and lower HbA1c and CRP than lower fiber consumption. A consumption of added sugars of ≥10 % of the energy intake is associated with a more adverse plasma lipids profile and higher CRP than lower intake. Conclusions: In people with type 2 diabetes, variations in the proportion of fat and carbohydrates of the diet, within the relatively narrow ranges recommended by different nutritional guidelines, significantly impact on the metabolic profile and markers of low-grade inflammation. The data support the potential for reducing the intake of fat and added sugars, preferring complex, slowly absorbable, carbohydrates.

Published
2016

7. The energy intake modulates the association of the-55CT polymorphism of UCP3 with body weight in type 2 diabetic patients International Journal of Obesity

Author

Lapice E, Monticelli A, Cocozza S, Pinelli M, Giacco A, Rivellese AA, Riccardi G, and Vaccaro O.

Subjects
polymorphism, type 2 diabetic, Obesity
Abstract

BACKGROUND: Previous association studies of the -55CT polymorphism of the uncoupling protein 3 (UCP3) gene with body mass index (BMI) have provided inconsistent results. The study aim is twofold: (1) to evaluate the association of the -55CT polymorphism of UCP3 with BMI in two independent populations to verify the reproducibility of the finding; (2) to evaluate whether this association is modulated by energy intake. METHODS: Study participants are 736 males and females with type 2 diabetes belonging to independent populations (N=394 population 1; N=342 population 2). Anthropometry and laboratory parameters were measured; in population 2, energy intake and physical exercise were also assessed. RESULTS: The -55CT polymorphism was associated with a significantly lower BMI in population 1 (27.8±3.9 vs 28.9±4.6 kg m(-2); P

Published
2014

8. The effect of age on the fecal microbiota

Author

Maukonen, Johanna, Hyytiäinen, T, Demmelmair, H, Foerster, J, Pietiläinen, KH, Annuzzi, G, Reinhardt, N, Veijola, R, Rivellese, AA, Boeing, H, Kaprio, J, Knip, M, Koletzko, B, Oresic, M, and Saarela, Maria

Published
2014

11. The TOSCA.IT trial: a study designed to evaluate the effect of pioglitazone versus sulfonylureas on cardiovascular disease in type 2 Diabetes

Author

Vaccaro, O, Masulli, M, Bonora, E, DEL PRATO, Stefano, Nicolucci, A, Rivellese, Aa, Riccardi, G, and IT Study Group, T. O. S. C. A.

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Disease, Type 2 diabetes, Hypoglycemia, cvd, law.invention, Therapeutic approach, Quality of life, Randomized controlled trial, law, cardiovascular disease, Diabetes mellitus, Internal Medicine, medicine, Humans, Hypoglycemic Agents, pioglitazone, Online Letters: Observations, sulfonylureas, Intensive care medicine, Aged, Advanced and Specialized Nursing, business.industry, type 2 diabetes, Middle Aged, medicine.disease, Surgery, Sulfonylurea Compounds, Treatment Outcome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Quality of Life, Female, Thiazolidinediones, business, Pioglitazone, medicine.drug
Abstract

The recently published American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) position statement on the management of hyperglycemia in type 2 diabetes (T2D) (1) underlines the complexity of the therapeutic approach in T2D. This is due to both the increasing number of available drugs and to the paucity of solid data on the superiority of one compound over the others. By and large, antidiabetic drugs reduce blood glucose to a similar extent but have different impacts on cardiovascular (CV) risk factors, durability of efficacy, safety, and possible added values (2–4). A major challenge for clinicians is to select treatments that are capable of achieving and maintaining glucose control for as long as possible while minimizing the risk of chronic complications, including cardiovascular disease (CVD). This goal should be pursued with minimal side effects (mainly hypoglycemia). Although there is agreement on …

Published
2012

12. Dietary carbohydrates for diabetics

Author

Rivellese AA, Giacco R, and Costabile G.

Subjects
Carbohydrates, Fiber, Glycemic Index, Glycemic control
Abstract

The literature on the impact of dietary carbohydrates in the regulation of blood glucose levels and other metabolic abnormalities in diabetic patients over the last 3 years is reviewed. We try to differentiate the metabolic effects due to the amount of carbohydrates from those due to their different types. The review comprises a part dealing with the effects of diets having low or high carbohydrate content on body weight reduction, and a part in which the amount and the quality of carbohydrates are discussed in relation to isoenergetic diets. Overall, the data accumulated in the period considered seem to confirm that the decrease in energy intake is more important than the qualitative composition of the diet to reduce body weight, but that both the amount and the quality of carbohydrates are important in modulating blood glucose levels and other cardiovascular risk factors in both the fasting and the postprandial phases in diabetic individuals.

Published
2012
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15. Prevenzione del diabete mellito tipo 2

Author

Del Prato, S, Sesti, G, Averna, M, DE FEO, Pierpaolo, Ferrannini, E, Giaccari, A, Giorgino, F, Miccoli, R, Rivellese, Aa, Sbraccia, P, Solini, A, and Trischitta, V.

Published
2011

16. Postprandial chylomicrons and adipose tissue lipoprotein lipase are altered in type 2 diabetes independently of obesity and whole-body insulin resistance

Author

Annuzzi G, Giacco R, Patti L, Di Marino L, De Natale C, Costabile G, Marra M, Santangelo C, Masella R, and Rivellese AA.

Subjects
lipids (amino acids, peptides, and proteins)
Abstract

BACKGROUND AND AIMS: Postprandial lipoprotein abnormalities in type 2 diabetes are associated with insulin resistance. The role of other diabetes-related factors is still not clear. The aim of this study is to differentiate the effects of whole-body insulin resistance, obesity, and type 2 diabetes on postprandial dyslipidaemia and lipoprotein lipase (LPL) in adipose tissue. METHODS AND RESULTS: Ten subjects with obesity and diabetes (OD), 11 with obesity alone (O), and 11 normal-weight controls (C) - males, aged 26-59 years, with fasting normo-triglyceridaemia underwent measurements of cholesterol, triglycerides, apo B-48 and apo B-100 concentrations in plasma lipoproteins separated by density gradient ultracentrifugation before and after a fat-rich meal. Fasting and postprandial (6h) LPL activity was determined in abdominal subcutaneous adipose tissue biopsy samples. Insulin sensitivity was measured by hyperinsulinaemic euglycaemic clamp. OD and O subjects had similar degrees of adiposity (BMI, waist circumference, fat mass) and insulin resistance (insulin stimulated glucose disposal and M/I). They also showed a similarly higher postprandial increase in large VLDL lipids (triglyceride incremental AUC 188+/-28 and 135+/-22 mg/dl.6h) than C (87+/-13 mg/dl.6h, M+/-SEM, p

Published
2008

21. Effects of fructo-oligosaccarides on glucose and lipid metabolism in mild hypercholesterolemic individuals

Author

Giacco R, Clemente G, Luongo D, F.Bornet F, Brouns F, Patti L, Lasorella G, Fiume I, Cipriano P, Rivellese AA, and Riccardi G

Subjects
Lipid metabolism, Fructo-oligosaccharides, Hyperlypidaemia, Colonic fermentation
Abstract

BACKGROUND: The intake of 10 g/day of short-chain-fructo-oligosaccharides (sc-FOS) has been shown to increase significantly bifidus counts and to produce high amounts of short-chain fatty acids (SCFA), presumed to influence glucose and lipid metabolism. AIM: To evaluate the effects of moderate intake of sc-FOS on glucose and lipid metabolism in individuals with mild hypercholesterolaemia. Design: A randomized double-blind sequential cross-over study. SUBJECTS AND METHODS: Thirty subjects of both genders (20 M/10 F), mean age 45.5+/-9.9 years (M+/-SD), BMI 26.6+/-2.2 kg/m(2), with plasma cholesterol >5.17 and

Published
2004
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23. Substituting dietary saturated for monounsaturated fat impairs insulinsensitivity in healthy men and women: The KANWU Study.

Author

Vessby, B, Unsitupa, M, Hermansen, K, Riccardi, G, Rivellese, AA, Tapsell, LC, Nalsen, C, Berglund, L, Louheranta, A, Rasmussen, BM, Calvert, GD, Maffetone, A, Pedersen, E, Gustafsson, IB, Storlien, LH, Vessby, B, Unsitupa, M, Hermansen, K, Riccardi, G, Rivellese, AA, Tapsell, LC, Nalsen, C, Berglund, L, Louheranta, A, Rasmussen, BM, Calvert, GD, Maffetone, A, Pedersen, E, Gustafsson, IB, and Storlien, LH

Published
2001

24. Pro12Ala polymorphism of the PPARgamma2 locus modulates the relationship between energy intake and body weight in type 2 diabetic patients.

Author

Vaccaro O, Lapice E, Monticelli A, Giacchetti M, Castaldo I, Galasso R, Pinelli M, Donnarumma G, Rivellese AA, Cocozza S, Riccardi G, Vaccaro, Olga, Lapice, Emanuela, Monticelli, Antonella, Giacchetti, Manuela, Castaldo, Imma, Galasso, Rocco, Pinelli, Michele, Donnarumma, Giovanna, and Rivellese, Angela A

Abstract

Objective: We explore the relationship among BMI, habitual diet, and the Pro12Ala polymorphism in the peroxisome proliferator-activated receptor (PPAR)gamma2.Research Design and Methods: The Pro12Ala variant was characterized in 343 unrelated type 2 diabetic patients who were consecutively seen at the outpatient clinic of a health district of the province of Naples. Anthropometric and laboratory parameters were measured; habitual diet was assessed by a validated semiquantitative food frequency questionnaire.Results: The overall frequency of Ala12 was 12% (n = 42). BMI was significantly higher in Ala carriers than non-Ala carriers, whereas total daily energy intake or macronutrient composition of the diet were similar in the two groups. For further analysis, participants were stratified according to genotype and sex-specific quartiles of energy intake. BMI increased in both genotype groups with increasing energy intake (P < 0.03). BMI was similar in Ala carriers and non-Ala carriers (30.0 vs. 30.1 kg/m2, P > 0.10) in the lower quartile of energy intake but significantly higher in Ala carriers in the upper quartile (36.0 vs. 32.1 kg/m2, P < 0.001). Average daily energy intake and diet composition were comparable within each quartile for carriers or noncarriers of the Ala allele. Relative to the noncarriers, Ala carriers had a significantly lower energy intake per kilogram body weight, thus suggesting that the Ala allele is associated with a higher food efficiency. The confounding role of medications, glucose control, and physical exercise was ruled out.Conclusions: This study provides evidence of a differential susceptibility to fat accumulation, and, hence, weight gain, in response to habitual high energy intake for Ala carriers compared with Pro/Pro homozygotes. [ABSTRACT FROM AUTHOR]

Published
2007
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25. Effects of dietary saturated, monounsaturated, and n-3 fatty acids on blood pressure in healthy subjects.

Author

Rasmussen BM, Vessby B, Uusitupa M, Bergland L, Pedersen E, Riccardi G, Rivellese AA, Tapsell L, Hermansen K, and KANWU Study Group

Abstract

BACKGROUND: The quantity and quality of fats consumed in the diet influence the risk of cardiovascular disease (CVD). Although the effect of diet on plasma lipids and lipoproteins is well documented, less information exists on the role of fats on blood pressure (BP). OBJECTIVE: The objective was to evaluate the effects of different types of dietary fat on BP in healthy subjects. DESIGN: Healthy subjects (n = 162) were randomly assigned for 3 mo to follow 1 of 2 isoenergetic diets: 1 rich in monounsaturated fatty acids (MUFA diet) and the other rich in saturated fatty acids (SFA diet). Each group was further randomly assigned to receive supplementation with fish oil (3.6 g n-3 fatty acids/d) or placebo. RESULTS: Systolic BP (SBP) and diastolic BP (DBP) decreased with the MUFA diet [-2.2% (P = 0.009) and -3.8% (P = 0.0001), respectively] but did not change with the SFA diet [-1.0% (P = 0.2084) and -1.1% (P = 0.2116)]. The MUFA diet caused a significantly lower DBP than did the SFA diet (P = 0.0475). Interestingly, the favorable effects of MUFA on DBP disappeared at a total fat intake above the median (>37% of energy). The addition of n-3 fatty acids influenced neither SBP nor DBP. CONCLUSIONS: Changing the proportions of dietary fat by decreasing SFAs and increasing MUFAs decreased diastolic BP. Interestingly, the beneficial effect on BP induced by fat quality was negated by the consumption of a high total fat intake. The addition of n-3 fatty acids to the diet had no significant effect on BP. [ABSTRACT FROM AUTHOR]

Published
2006

26. The pathophysiology of lipid metabolism and diabetes.

Author

Rivellese AA, Vaccaro O, and Patti L

Abstract

Patients with diabetes often present with abnormal lipid profiles because insulin regulates several of the steps of lipid metabolism. Patients with type 1 diabetes that exhibit effective glycaemic control do not have quantitative lipoprotein abnormalities, but may exhibit qualitative abnormalities, mainly an increase in smaller, more atherogenic very low-density lipoprotein (VLDL) particles. Furthermore, in the Diabetes Control and Complications Trials (DCCT) study, the group of patients with type 1 diabetes that were characterised by consistent weight gain, exhibited lipid profiles more typical of type 2 diabetes (T2D). Dyslipidaemia in T2D is characterised by several strictly linked abnormalities: elevated fasting and postprandial triglycerides (TG), a significant decrease in high-density lipoprotein (HDL) cholesterol and an increase in smaller low-density lipoprotein (LDL) and HDL particles. The increase in plasma TG is largely explained by the increased production of TG-rich; large-sized VLDL in particular. The insulin resistant liver fails to inhibit lipid attachment to pre-VLDL molecules and synthesises larger-sized VLDL at a greater rate. Large TG-rich; VLDL enhances the transfer of core lipids between VLDL, LDL, and HDL with increased formation of smaller LDL and HDL. Also, the elevated postprandial TG that are often present in patients with T2D may be linked to insulin resistance. Therefore, the abatement of hyperglycaemia and insulin resistance should be one of the main treatment objectives to address dyslipidaemia in patients with diabetes. [ABSTRACT FROM AUTHOR]

Published
2004
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28. Long-term dietary treatment with increased amounts of fiber-rich low-glycemic index natural foods improves blood glucose control and reduces the number of hypoglycemic events in type 1 diabetic patients.

Author

Giacco R, Parillo M, Rivellese AA, Lasorella G, Giacco A, D'Episcopo L, Riccardi G, Giacco, R, Parillo, M, Rivellese, A A, Lasorella, G, Giacco, A, D'Episcopo, L, and Riccardi, G

Abstract

Objective: To evaluate in type 1 diabetic patients 1) the long-term feasibility of a high-fiber (HF) diet composed exclusively of natural foodstuffs and 2) the efficacy of this diet in relation to blood glucose control and incidence of hypoglycemic episodes.Research Design and Methods: The study was randomized with parallel groups. Participants were part of a larger multicenter study on the effects of acarbose on glucose control in diabetes. A total of 63 type 1 diabetic patients, age 28 +/- 9 years, BMI 24 +/- 0.6 kg/m2, after a 4-week run-in period on their habitual diet, were randomized to either an HF (n = 32) or a low-fiber (LF) diet (n = 31) for 24 weeks. The two diets, composed exclusively of natural foodstuffs, were weight-maintaining and, aside from their fiber content, were similar for all nutrients. At the end of the run-in period and the dietary treatment, fasting blood samples for the measurement of plasma cholesterol, HDL cholesterol, triglyceride, and HbA(1c) were collected. A daily glycemic profile was performed on a day in which the participants had consumed a standard menu representative of their treatment diet (HF or LF).Results: Of the 63 study subjects, 29 in the HF group (91%) and 25 in the LF group (81%) completed the study Compared with the LF diet, the HF diet after 24 weeks decreased both mean daily blood glucose concentrations (P < 0.05) and number of hypoglycemic events (P < 0.01). When compliance to diet was taken into account, 83% of the subjects on the HF diet and 88% on the LF diet were compliant. In this subgroup, compared with the LF diet, the HF diet significantly reduced mean daily blood glucose concentrations (P < 0.001), HbA(1c) (P < 0.05), and number of hypoglycemic events (P < 0.01).Conclusions: In type 1 diabetic patients, an HF diet is feasible in the long term and, compared with an LF diet, improves glycemic control and reduces the number of hypoglycemic events. [ABSTRACT FROM AUTHOR]

Published
2000
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31. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

Author

Vitale, M., Masulli, M., Rivellese, A. A., Bonora, E., Cappellini, F., Nicolucci, Andrea, Squatrito, S., Antenucci, D., Barrea, A., Bianchi, C., Bianchini, F., Fontana, L., Fornengo, P., Giorgino, F., Gnasso, A., Mannucci, E., Mazzotti, A., Nappo, R., Palena, A. P., Pata, P., Perriello, G., Potenziani, S., Radin, R., Ricci, L., Romeo, F., Santini, C., Scarponi, M., Serra, Riccardo, Timi, A., Turco, A. A., Vedovato, M., Zavaroni, D., Grioni, S., Riccardi, G., Vaccaro, O., Rivellese, Angela Albarosa, Cocozza, Sara, Auciello, Stefania, Turco, Anna Amelia, Bonora, Enzo, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Tomasetto, Elena, Perriello, Gabriele, Timi, Alessia, Squatrito, Sebastiano, Sinagra, Tiziana, Longhitano, Sara, Tropea, Vanessa, Ballardini, Giorgio, Babini, Anna Carla, Ripani, Raffaella, Gregori, Giovanna, Dolci, Maria, Bruselli, Laura, Salutini, Isabella, Mori, Mary, Baccetti, Fabio, Lapolla, Annunziata, Sartore, Giovanni, Burlina, Silvia, Chilelli, Nino Cristiano, Buzzetti, Raffaella, Venditti, Chiara, Potenziani, Stella, Carlone, Angela, Galluzzoâ€&nbsp, Aldo, Giordano, Carla, Torregrossa, Vittoria, Corsi, Laura, Cuneo, Giacomo, Corsi, Simona, Tizio, Biagio, Clemente, Gennaro, Citro, Giuseppe, Natale, Maria, Salvatore, Vita, Di Cianni, Graziano, Lacaria, Emilia, Russo, Laura, Iannarelli, Rossella, de Gregorio, Antonella, Sciarretta, Filomena, D’Andrea, Settimio, Montani, Valeria, Cannarsa, Emanuela, Dolcetti, Katia, Cordera, Renzo, Bonabello, Laura Affinito, Mazzucchelli, Chiara, Giorda, Carlo Bruno, Romeo, Francesco, Bonetto, Caterina, Antenucci, Daniela, Baldassarre, Maria Pompea Antonia, Iovine, Ciro, Nappo, Rossella, Ciano, Ornella, Dall’Aglio, Elisabetta, Mancastroppa, Giovanni, Grimaldi, Franco, Tonutti, Laura, Boemi, Massimo, D’Angelo, Federica, Leotta, Sergio, Fontana, Lucia, Lauro, Davide, Rinaldi, Maria Elena, Cignarelli, Mauro, la Macchia, Olga, Fariello, Stefania, Tomasi, Franco, Zamboni, Chiara, Dozio, Nicoletta, Trevisan, Roberto, Scaranna, Cristiana, Del Prato, Stefano, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Pugliese, Giuseppe, Salvi, Laura, Rangel, Graziela, Vitale, Martina, Anichini, Roberto, Tedeschi, Anna, Corsini, Elisa, Cucinotta, Domenico, Di Benedetto, Antonino, Giunta, Loretta, Ruffo, Maria Concetta, Bossi, Antonio Carlo, Carpinter, Rita, Dotta, Francesco, Ceccarelli, Elena, Bartolo, Paolo Di, Caselli, Chiara, Luberto, Alessandra, Santini, Costanza, Mazzotti, Arianna, Calbucci, Giovanni, Consoli, Agostino, Ginestra, Federica, Calabrese, Maria, Zogheri, Alessia, Ricci, Lucia, Giorgino, Francesco, Laviola, Luigi, Ippolito, Claudia, Tarantino, Lucia, Avogaro, Angelo, Vedovato, Monica, Gnasso, Agostino, Carallo, Claudio, Scicchitano, Caterina, Zavaroni, Donatella, Livraga, Stefania, Perin, Paolo Cavallo, Forrnengo, Paolo, Prinzis, Tania, de Cosmo, Salvatore, Palena, Antonio Pio, Bacci, Simonetta, Mannucci, Edoardo, Lamanna, Caterina, Pata, Pietro, Lettina, Gabriele, Aiello, Antimo, Barrea, Angelina, Lalli, Carlo, Scarponi, Maura, Franzetti, Ivano, Radin, Raffaella, Serra, Rosalia, Petrachi, Francesca, Asprino, Vincenzo, Capra, Claudio, Forte, Elisa, Reggiani, Giulio Marchesini, Forlani, Gabriele, Montesi, Luca, Mazzella, Natalia, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Auletta, Pasquale, Petraroli, Ettore, Capobianco, Giuseppe, Romano, Geremia, Cutolo, Michele, de Simone, Giosetta, Caiazzo, Gennaro, Nunziata, Peppe, Sorrentino, Susy, Amelia, Umberto, Calatola, Pasqualino, Capuano, Gelsomina, Vitale, M, Masulli, M, Rivellese, AA, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo,P, Giorgino, F, Gnasso, A, Mannucci, Mazzotti, A, Nappo, R, Palena, AP, Pata, P,Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, AA, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, TOSCA.IT Study Group., Giordano, C., Rivellese, Aa, Fornengo, P, Mannucci, E, Mazzotti, A, Nappo, R, Palena, Ap, Pata, P, Perriello, G, Turco, Aa, Tosc, A. IT Study Group., Rivellese, A, Palena, A, Turco, A, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, and Capuano, G

Subjects
0301 basic medicine, Male, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Aged, Antioxidants, Beverages, Cinnamates, Cohort Studies, Cross-Sectional Studies, Databases, Factual, Diabetes Mellitus, Type 2, Female, Flavonoids, Fruit, Glycosides, Humans, Italy, Male, Middle Aged, Nutritive Value, Phenols, Polyphenols, Diet, Diabetic, Diet, Healthy, Patient Compliance, Settore MED/09 - Medicina Interna, Databases, Factual, Cross-sectional study, Medicine (miscellaneous), Type 2 diabetes, Diabete, Antioxidants, Settore MED/13 - Endocrinologia, Food group, Cohort Studies, 0302 clinical medicine, Diet, Diabetic, Medicine, Food science, Glycosides, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Nutrition and Dietetics, Phenolic acid, food and beverages, Middle Aged, Polyphenols, Flavonoids, Phenolic acids, Diabetes, Food groups, Diet, Age, BMI, Geographical area, Intake, TOSCA.IT study, Italy, Tosca,Age,BMI,Diabetes,Diet,Flavonoids,Food groups,Geographical area,Intake,Phenolic acids,Polyphenols,TOSCA.IT study, Cohort, Female, Diet, Healthy, Nutritive Value, Cohort study, Polyphenol, 030209 endocrinology & metabolism, Beverages, 03 medical and health sciences, Phenols, Diabetes mellitus, Humans, Aged, 030109 nutrition & dietetics, business.industry, Anthropometry, medicine.disease, Tosca, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Cinnamates, Fruit, Flavonoid, Patient Compliance, business
Abstract

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50–75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes. © 2016 Springer-Verlag Berlin Heidelberg

Published
2016
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33. Joint position statement on 'Nutraceuticals for the treatment of hypercholesterolemia' of the Italian Society of Diabetology (SID) and of the Italian Society for the Study of Arteriosclerosis (SISA)

Author

A.A. Rivellese, Federico Bernini, C. Vetrani, Clara Bianchi, Massimo Raffaele Mannarino, Matteo Pirro, Pirro, M, Vetrani, C, Bianchi, C, Mannarino, Mr, Bernini, F, and Rivellese, Aa

Subjects
0301 basic medicine, medicine.medical_specialty, Consensus, Berberine, Endocrinology, Diabetes and Metabolism, Hypercholesterolemia, Cholesterol, Fiber, Nutraceuticals, Phytosterols, Policosanol, Red yeast rice, Soy, Medicine (miscellaneous), Down-Regulation, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Nutraceutical, Risk Factors, Phytosterol, medicine, Humans, 030109 nutrition & dietetics, Nutrition and Dietetics, Traditional medicine, business.industry, Patient Selection, Diabetology, Evidence-based medicine, Arteriosclerosis, Cholesterol, LDL, medicine.disease, Biotechnology, Clinical trial, Treatment Outcome, chemistry, Dietary Supplements, Cardiology and Cardiovascular Medicine, business, Biomarkers, medicine.drug
Abstract

Aim Evidence showed that LDL-cholesterol lowering is associated with a significant cardiovascular risk reduction. The initial therapeutic approach to hypercholesterolemia includes dietary modifications but the compliance to recommendations is often inadequate. Some dietary components with potential cholesterol-lowering activity are present in small amounts in food. Therefore, in recent years the use of “nutraceuticals” (i.e., nutrients and/or bioactive compounds with potential beneficial effects on human health) has become widespread. Such substances may be added to foods and beverages, or taken as dietary supplements (liquid preparations, tablets, capsules). In the present manuscript, the cholesterol-lowering activity of some nutraceuticals (i.e. fiber, phytosterols, soy, policosanol, red yeast rice and berberine) will be discussed along with: 1) the level of evidence on the cholesterol-lowering efficacy emerging from clinical trial; 2) the possible side effects associated with their use; 3) the categories of patients who could benefit from their use. Data synthesis Based on the current literature, the cholesterol-lowering effect of fiber, phytosterols and red yeast rice is consistent and supported by a good level of evidence. Over berberine, there is sufficient evidence showing significant cholesterol-lowering effects, although the results come from studies carried out almost exclusively in Asian populations. Data on the effects of soy are conflicting and, therefore, the strength of recommendation is quite low. The evidence on policosanol is inconclusive. Conclusion Although health benefits may arise from the use of nutraceuticals with cholesterol-lowering activity, their use might be also associated with possible risks and pitfalls, some of which are common to all nutraceuticals whereas others are related to specific nutraceuticals.

Published
2016

34. Functional foods and cardiometabolic diseases: International Task Force for Prevention of Cardiometabolic Diseases

Author

Assmann G, Buono P, Daniele A, Della Valle E, Farinaro E, Ferns G, Krogh V, Kromhout D, Luis Masana, Merino J, Misciagna G, Panico S, Riccardi G, Aa, Rivellese, Rozza F, Salvatore F, Salvatore V, Stranges S, Trevisan M, Trimarco B, Vetrani C, Assmann, G, Buono, P, Daniele, A, DELLA VALLE, Elisabetta, Farinaro, Eduardo, Ferns, G, Krogh, V, Kromhout, D, Masana, L, Merino, J, Misciagna, G, Panico, Salvatore, Riccardi, Gabriele, Rivellese, ANGELA ALBAROSA, Rozza, Francesco, Salvatore, F, Salvatore, V, Stranges, S, Trevisan, M, Trimarco, Bruno, Vetrani, C., Daniele, Aurora, Della Valle, E, Farinaro, E, Panico, S, Riccardi, G, Rivellese, Aa, Rozza, F, and Trimarco, B

Subjects
Nutritional genomic, Functional food, functional foods, cardiometabolic diseases, prevention, Feeding Behavior, Diet, Mediterranean, Diet Surveys, Epigenesis, Genetic, Cardiometabolic disease, Nutrigenomics, Cardiovascular Diseases, Animals, Humans, Nutritional genomics, Caloric Restriction
Abstract

Mounting evidence supports the hypothesis that functional foods containing physiologically-active components may be healthful. Longitudinal cohort studies have shown that some food classes and dietary patterns are beneficial in primary prevention, and this has led to the identification of putative functional foods. This field, however, is at its very beginning, and additional research is necessary to substantiate the potential health benefit of foods for which the diet-health relationships are not yet scientifically validated. It appears essential, however, that before health claims are made for particular foods, in vivo randomized, double-blind, placebo-controlled trials of clinical end-points are necessary to establish clinical efficacy. Since there is need for research work aimed at devising personalized diet based on genetic make-up, it seems more than reasonable the latter be modeled, at present, on the Mediterranean diet, given the large body of evidence of its healthful effects. The Mediterranean diet is a nutritional model whose origins go back to the traditional diet adopted in European countries bordering the Mediterranean sea, namely central and southern Italy, Greece and Spain; these populations have a lower incidence of cardiovascular diseases than the North American ones, whose diet is characterized by high intake of animal fat. The meeting in Naples and this document both aim to focus on the changes in time in these two different models of dietary habits and their fall out on public health.

Published
2014

36. Plasma homocysteine and microvascular complications in type 1 diabetes

Author

Vaccaro O, Alessandra PERNA, Fp, Mancini, Iovine C, Cuomo V, Sacco M, Tufano A, Aa, Rivellese, Ingrosso D, Riccardi G, Vaccaro, Olga, Perna, Af, Mancini, Fp, Iovine, Ciro, Cuomo, V, Sacco, M, Tufano, Antonella, Rivellese, ANGELA ALBAROSA, Ingrosso, Diego, Riccardi, Gabriele, Vaccaro, O, Perna, Alessandra, Iovine, C, Tufano, A, Rivellese, Aa, and Riccardi, G.

Subjects
Adult, Male, Oxidoreductases Acting on CH-NH Group Donors, Diabetic Retinopathy, Vitamin B 12, Diabetes Mellitus, Type 1, Folic Acid, Case-Control Studies, Creatinine, Albuminuria, Humans, Point Mutation, Diabetic Nephropathies, Female, Homocysteine, Diabetic Angiopathies, Methylenetetrahydrofolate Reductase (NADPH2)
Abstract

Background. Homocysteine is involved in a complex and dynamic system of vascular injury and repair and may thus contribute to the development of diabetic microangiopathy. This still debated issue has important scientific and clinical implications, since hyperhomocysteinemia can be corrected nutritionally.Aims. 1) To evaluate the association between fasting plasma homocysteine, type I diabetes and its microvascular complications; 2) to elucidate the basis of this association by investigating the major determinants of plasma homocysteine in relation to diabetic microangiopathy.Methods. We studied sixty-six consecutive patients with type 1 diabetes mellitus of >10 years duration and normal serum creatinine (mol/L, 1.3 mg/dL), and free from clinically detectable cardiovascular diseases. Forty;four non-diabetic controls were also studied. Plasma concentrations of homocysteine, folate and vitamin B12 were investigated together with the C677T mutation in the gene coding for methylenetetrahydrofolate reductase (MTHFR), a key enzyme in homocysteine metabolism. Renal and retinal diabetic complications were evaluated as albumin/creatinine ratio on early-morning urine spot collection and fundus photographs.Findings. Fasting plasma homocysteine levels were very similar in patients and controls. Patients with microalbuminuria or proliferative retinopathy had significantly higher values than those without: 9.4 +/-3.1 vs 7.4 +/-2.8 mu mol/L, p2.6 vs 7.3 +/-3.0 mu mol/L, p

Published
2001

37. Effects of Mediterranean Diet on Endothelial Reactivity in Individuals with High Cardiometabolic Risk: A Randomized Controlled Parallel-Group Preliminary Trial.

Author

Lupoli R, Calcaterra I, Ambrosino P, Giacco R, Vitale M, Della Pepa G, Rivellese AA, Iannuzzo G, Bozzetto L, and Di Minno M

Abstract

Background: Endothelial dysfunction is recognized as an early modification involved in the pathogenesis of vascular diseases. Evidence suggests that the Mediterranean Diet (MD) is associated with endothelial function improvement and, in turn, plays an important role in atherosclerosis development and progression., Objectives: To evaluate both acute and sustained effects of the MD on endothelial function in patients with high cardiometabolic risk., Methods: A total of 25 subjects were randomly assigned to either the MD group or the Control Diet (CD) group according to a single-blind, parallel-group study design. Endothelial function was evaluated through non-invasive flow-mediated dilation (FMD) measurements at baseline (T0) and after 8 weeks (Tw8) of the MD or CD intervention, under both 12 h fast condition (fasting) and 2 h post-meal resembling the assigned diet (2 h). Assessments were conducted by a blinded sonographer., Results: FMD at T0-fasting was similar between MD and CD groups (6.11% ± 0.67 vs. 7.90% ± 1.65; p = 0.266). A significant difference in FMD between MD and CD groups was observed at T0-2h (12.14% ± 1.93 vs. 4.01% ± 1.03; p = 0.004), T8w-fasting (9.76% ± 1.18 vs. 5.03% ± 0.89; p = 0.008), and T8w-2h (8.99% ± 1.22 vs. 3.86% ± 0.52; p = 0.003). Oral glucose insulin sensitivity (OGIS) at T0 correlated with FMD percent changes from T0-fasting to T0-2h (r = 0.414, p = 0.044). After adjusting for age, gender, and OGIS, MD was an independent predictor of percent changes in FMD from T0-fasting to T0-2h (β: -0.582, p = 0.003), from T0-fasting to T8w-fasting (β: -0.498, p = 0.013), and from T0-fasting to T8w-2h (β: -0.479, p = 0.018)., Conclusions: Adherence to the MD may improve endothelial function in both the short- and medium-term among patients at high cardiometabolic risk.

Published
2024
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38. Blood glucose control and metabolic dysfunction-associated steatotic liver disease in people with type 1 diabetes.

Author

Della Pepa G, Lupoli R, Masulli M, Boccia R, De Angelis R, Gianfrancesco S, Piccolo R, Rainone C, Rivellese AA, Annuzzi G, and Bozzetto L

Subjects
Humans, Male, Female, Cross-Sectional Studies, Adult, Middle Aged, Glycemic Control methods, Fatty Liver blood, Fatty Liver complications, Fatty Liver diagnosis, Fatty Liver etiology, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 1 blood, Blood Glucose analysis, Blood Glucose metabolism
Abstract

Purpose: Metabolic dysfunction-associated steatotic liver disease (MASLD) may have distinctive pathophysiological features in type 1 diabetes (T1D). We evaluated the independent role of blood glucose control on MASLD in T1D., Methods: In a cross-sectional study on 659 T1D adult patients, MASLD was assessed by the Fatty Liver Index (FLI) and the Hepatic Steatosis Index (HSI). Anthropometric, biochemical, and clinical parameters were retrieved from electronic records. Blood glucose control status was evaluated by dividing participants into subgroups according to the median value of HbA1c [7.6% (60 mmol/mol)], and this analysis was repeated excluding overweight/obese patients., Results: Patients with HbA1c above 7.6% (60 mmol/mol) showed significantly higher MASLD indices (HSI 38 ± 6 vs. 36 ± 5, p < 0.001; FLI 26 ± 26 vs.19 ± 19, p < 0.001), and higher proportions of MASLD identified by HSI (57 vs. 44%, p < 0.001) and FLI (14 vs. 7%, p < 0.001) than patients with HbA1c below 7.6% (60 mmol/mol). Similar results were obtained for HSI after the exclusion of overweight/obese patients. Stepwise linear regression analysis confirmed that HbA1c was independently associated with HSI (r = 0.496, p = 0.009) and FLI (r = 0.722, p = 0.007); waist circumference with HSI (r = 0.492, p < 0.001); and waist circumference (r = 0.700, p < 0.001), HDL cholesterol (r = 0.719, p < 0.001), and LDL cholesterol (r = 0.712, p < 0.001) with FLI., Conclusions: Blood glucose control is a main factor associated with MASLD in adults with T1D, also independently of overweight and obesity. Appropriate therapeutic strategies focused on tight blood glucose control may also be needed for the prevention and treatment of MASLD in T1D., (© 2024. The Author(s).)

Published
2024
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39. Clusters of adipose tissue dysfunction in adults with type 2 diabetes identify those with worse lipidomic profile despite similar glycaemic control.

Author

Della Pepa G, Carli F, Sabatini S, Pezzica S, Russo M, Vitale M, Masulli M, Riccardi G, Rivellese AA, Vaccaro O, Bozzetto L, and Gastaldelli A

Subjects
Adult, Humans, Glycated Hemoglobin, Glycemic Control, Lipidomics, Fatty Acids, Adipose Tissue, Fatty Acids, Nonesterified, Insulin, Insulin Resistance, Diabetes Mellitus, Type 2
Abstract

Aims: To investigate clusters of adipose tissue dysfunction, that is, with adipose tissue insulin resistance (ADIPO-IR) and large waist circumference (WC), identify a worse lipidomic profile characterised by a high proportion of lipids rich in saturated fatty acids (SFA)., Materials and Methods: Hierarchical clustering based on WC and ADIPO-IR (calculated as fasting plasma non-esterified fatty acids times fasting plasma insulin, FFA×INS), was performed in 192 adults with overweight/obesity and type 2 diabetes (T2D) treated with metformin (HbA1c = 7.8%). Free fatty acid composition and lipidomic profile were measured by mass spectrometry (GC-MS and LC-MSQTOF). Indexes of fatty acid desaturation (stearoyl-coA desaturase-1 activity, SCD1 16  = palmitoleic acid/palmitic acid and SCD1 18  = oleic acid/stearic acid) and of insulin resistance (HOMA-IR) were also calculated., Results: Three clusters were identified: CL1 (ADIPO-IR = 4.9 ± 2.4 and WC = 96±7 cm, mean ± SD), CL2 (ADIPO-IR = 6.5 ± 2.5 and WC = 114 ± 7 cm), and CL3 (ADIPO-IR = 15.0 ± 4.7 and WC = 107 ± 8 cm). Insulin concentrations, ADIPO-IR, and HOMA-IR significantly increased from CL1 to CL3 (all p < 0.001), while fasting glucose concentrations, HbA1c, dietary lipids and caloric intake were similar. Moreover, CL3 showed significantly higher concentrations of monounsaturated free fatty acids, oleic and palmitoleic acids, triglycerides (TAG) rich in saturated FA and associated with de novo lipogenesis (i.e., TAG 46-50), higher SCD1 16, SCD1 18 , ceramide (d18:0/18:0), and phosphatidylcholine aa(36:5) compared with CL1/CL2 (all p < 0.005)., Conclusions: High ADIPO-IR and large WC identify a worse lipid profile in T2D characterised by complex lipids rich in SFA, likely due to de novo synthesis given higher plasma monounsaturated FFA and increased desaturase activity indexes., Registration Number Trial: ID NCT00700856 https://clinicaltrials.gov., (© 2024 John Wiley & Sons Ltd.)

Published
2024
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40. Differential Effects of Two Isocaloric Healthy Diets on Postprandial Lipid Responses in Individuals with Type 2 Diabetes.

Author

Costabile G, Salamone D, Della Pepa G, Vitale M, Testa R, Cipriano P, Scidà G, Rivellese AA, Annuzzi G, and Bozzetto L

Subjects
Humans, Male, Female, Cholesterol, HDL, Diet, Healthy, Postprandial Period, Triglycerides, Cholesterol, Lipoproteins, Dietary Fats, Cross-Over Studies, Diabetes Mellitus, Type 2
Abstract

Background: High blood concentrations of triglycerides (TG) in the postprandial period have been shown to be more closely associated with the risk of cardiovascular disease (CVD) than fasting values in individuals with type 2 diabetes (T2D). Dietary changes are the primary determinants of postprandial lipid responses., Methods: We investigated the effects of an isocaloric multifactorial diet, rich in n-3 PUFA, MUFA, fiber, polyphenols, and vitamins, compared to an isocaloric diet, containing the same amount of MUFA, on the postprandial lipid response in T2D individuals. Following a randomized, controlled, parallel group design, 43 (25 male/18 female) T2D individuals were assigned to an isocaloric multifactorial (n = 21) or a MUFA-rich diet (n = 22). At the beginning and after the 8 weeks of dietary intervention, the concentrations of plasma triglycerides, total cholesterol, HDL cholesterol, and non-HDL cholesterol were detected at fasting and over a 4-h test meal with the same composition as the prescribed diet., Results: The concentrations of fasting plasma triglycerides, total cholesterol, HDL cholesterol, and non-HDL cholesterol did not change after both diets. Compared with the MUFA diet, the 8-week multifactorial diet significantly lowered the postprandial response, which was evaluated as the incremental area under the curve (iAUC), of triglycerides by 33% (64 ± 68 vs. 96 ± 50 mmol/L·240 min, mean ± SD, respectively, p = 0.018), total cholesterol by 105% (-51 ± 33 vs. -25 ± 29, p = 0.013), and non-HDL cholesterol by 206% (-39 ± 33 vs. -13 ± 23, p = 0.013)., Conclusions: In T2D individuals, a multifactorial diet, characterized by several beneficial components, improved the postprandial lipid response compared to a MUFA diet, generally considered a healthy diet being reduced in saturated fat, and probably contributed to the reduction of cardiovascular risk.

Published
2024
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41. Dietary micronutrient adequacies and adherence to the Mediterranean diet in a population of older adults with type 2 diabetes: A cross-sectional study.

Author

Massimino E, Izzo A, Castaldo C, Amoroso AP, Rivellese AA, Capaldo B, and Della Pepa G

Subjects
Male, Humans, Female, Aged, Cross-Sectional Studies, Calcium, Magnesium, Vitamins, Riboflavin, Vitamin B 6, Vitamin E, Diet, Mediterranean, Diabetes Mellitus, Type 2, Selenium, Niacin
Abstract

Background and Aims: There are few data on micronutrient intake in older adults with type 2 diabetes (T2D) and their adherence to the Mediterranean diet, a dietary pattern rich in micronutrients. In this cross-sectional study, we evaluated the prevalence of adequacy in micronutrient intake according to the recommendations, and the adherence to the Mediterranean diet in older adults with T2D., Methods: One hundred thirty-eight patients (47 women and 91 men) with T2D aged over 65 years were included. Dietary habits were assessed by three 24-h dietary recalls. The micronutrient intake, expressed as mean daily intake, and adequacy were compared with the dietary recommendations proposed by the Italian Society of Human Nutrition (LARN) and the European Food Safety Agency (EFSA). Adherence to the Mediterranean diet was evaluated by the MEDI-quest score., Results: An extremely low proportion of participants (∼1%) adhered to the recommendations for potassium and vitamin D intake. A low proportion of participants adhered to the recommendations for calcium (∼23%), magnesium (∼16%), selenium (∼17%), vitamin E (∼14%), riboflavin (∼28%), vitamin B 6 (∼29%), folate (∼25%), and niacin (∼27%) intake. More than 60% of the population adhered to the recommendations for iron, copper, vitamin A and B 12 intake. Only 53% of the population showed high adherence to the Mediterranean diet., Conclusions: Our data indicate that a very low proportion of older adults with T2D meet the recommendations for ten micronutrients (calcium, potassium, magnesium, selenium, vitamin D, vitamin E, riboflavin, vitamin B 6 , folate, and niacin) with an unsatisfactory adherence to the Mediterranean diet. Nutritional approaches aimed at favoring adherence to dietary recommendations and increasing the consumption of foods rich in micronutrients should be implemented in older adults., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2023 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Published
2023
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42. Consensus document on Lipoprotein(a) from the Italian Society for the Study of Atherosclerosis (SISA).

Author

Chiesa G, Zenti MG, Baragetti A, Barbagallo CM, Borghi C, Colivicchi F, Maggioni AP, Noto D, Pirro M, Rivellese AA, Sampietro T, Sbrana F, Arca M, Averna M, and Catapano AL

Subjects
Humans, Lipoprotein(a) genetics, Proprotein Convertase 9, Consensus, Atherosclerosis diagnosis, Atherosclerosis epidemiology, Atherosclerosis genetics, Aortic Valve Stenosis
Abstract

Aims: In view of the consolidating evidence on the causal role of Lp(a) in cardiovascular disease, the Italian Society for the Study of Atherosclerosis (SISA) has assembled a consensus on Lp(a) genetics and epidemiology, together with recommendations for its measurement and current and emerging therapeutic approaches to reduce its plasma levels. Data on the Italian population are also provided., Data Synthesis: Lp(a) is constituted by one apo(a) molecule and a lipoprotein closely resembling to a low-density lipoprotein (LDL). Its similarity with an LDL, together with its ability to carry oxidized phospholipids are considered the two main features making Lp(a) harmful for cardiovascular health. Plasma Lp(a) concentrations vary over about 1000 folds in humans and are genetically determined, thus they are quite stable in any individual. Mendelian Randomization studies have suggested a causal role of Lp(a) in atherosclerotic cardiovascular disease (ASCVD) and aortic valve stenosis and observational studies indicate a linear direct correlation between cardiovascular disease and Lp(a) plasma levels. Lp(a) measurement is strongly recommended once in a patient's lifetime, particularly in FH subjects, but also as part of the initial lipid screening to assess cardiovascular risk. The apo(a) size polymorphism represents a challenge for Lp(a) measurement in plasma, but new strategies are overcoming these difficulties. A reduction of Lp(a) levels can be currently attained only by plasma apheresis and, moderately, with PCSK9 inhibitor treatment., Conclusions: Awaiting the approval of selective Lp(a)-lowering drugs, an intensive management of the other risk factors for individuals with elevated Lp(a) levels is strongly recommended., Competing Interests: Declaration of competing interest APM received personal fees from AstraZeneca, Bayer, Novartis for the participation in study committees, outside the present work. M Arca has received research grant support and lecturing fees from Alfasigma, Amarin, Amgen, Amryt, IONIS/Akcea Therapeutics, Daiichi Sankyo, Novartis, Pfizer, Regeneron and Sanofi, SOBI. ALC in the last three years has received honoraria, lecture fees or research grants from Aegerion, Akcea Therapeutics, Amarin, Amgen, Amryt Pharma, AstraZeneca, Daiichi Sankyo, Esperion, Ionis Pharmaceutical, Medscape Education, Menarini, Merck, Mylan, Novartis, PeerVoice, Pfizer, Recordati, Regeneron, Sanofi, The Corpus, Viatris. GC, MGZ, AB, CMB, CB, FC, DN, MP, AAR, TS, FS, M Averna declare no competing interest., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2023
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43. Insulin pump therapy in type 1 diabetes is associated with lower indices of Non-Alcoholic Fatty Liver in non-obese women but not men.

Author

Pepa GD, Lupoli R, Masulli M, Boccia R, De Angelis R, Gianfrancesco S, Rainone C, Rivellese AA, Annuzzi G, and Bozzetto L

Subjects
Humans, Female, Hypoglycemic Agents therapeutic use, Glycated Hemoglobin, Injections, Subcutaneous, Insulin therapeutic use, Insulin, Regular, Human therapeutic use, Insulin Infusion Systems, Diabetes Mellitus, Type 1 drug therapy, Non-alcoholic Fatty Liver Disease drug therapy
Abstract

Aim: Non-Alcoholic Fatty Liver Disease (NAFLD) is a raising concern in type 1 diabetes (T1D) patients. We evaluated whether multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) may differentially affect NAFLD., Methods: NAFLD was assessed by Fatty Liver Index (FLI) and Hepatic Steatosis Index (HSI) in 659 T1D patients treated by MDI (n = 414, 65% men) or CSII (n = 245, 50% men) without alcohol abuse or other liver diseases. Clinical and metabolic differences between MDI and CSII participants were also evaluated according to sex., Results: Compared with the MDI cohort, CSII users had a significantly lower FLI (20.2 ± 21.2 vs. 24.8 ± 24.3; p = 0.003), HSI (36.2 ± 4.4 vs. 37.4 ± 4.4; p = 0.003), waist circumference (84.6 ± 11.8 vs. 86.9 ± 13.7 cm; p = 0.026), plasma triglyceride (76.0 ± 45.8 vs. 84.7 ± 58.3 mg/dl; p = 0.035), and daily insulin dose (0.53 ± 0.22 vs. 0.64 ± 0.25 IU/kg body weight; p < 0.001). In CSII users, lower FLI and HSI were observed in women (p = 0.009 and p = 0.033, respectively) but not in men (p = 0.676 and p = 0.131, respectively). Women on CSII also had lower daily insulin doses, plasma triglyceride, and visceral adiposity index than women on MDI., Conclusion: CSII is associated with lower NAFLD indices in women with T1D. This may relate to the lower peripheral insulin in the context of a permissive hormonal milieu., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Published
2023
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44. Risk of Sarcopenia and Associated Factors in Older Adults with Type 2 Diabetes: An Exploratory Cross-Sectional Study.

Author

Massimino E, Izzo A, Castaldo C, Ferretti E, Rivellese AA, and Della Pepa G

Abstract

Background: Evidence on the risk of sarcopenia and associated factors in older adults with type 2 diabetes (T2D) is lacking. We evaluate (1) the proportion of patients at risk of sarcopenia in older adults with T2D; and (2) the factors associated with the risk of sarcopenia., Methods: We conducted a cross-sectional study on T2D patients over 65 years referred to our outpatient clinic and who carried out the yearly complication assessment visit. Eligible patients were administered questionnaires during phone interviews for the risk evaluation of sarcopenia (SARC-F), the risk evaluation of malnutrition (Mini Nutritional Assessment Short Form (MNA ® -SF)), the adherence to the Mediterranean diet (MEDI-quest), and the evaluation of physical activity (the International Physical Activity Questionnaire short form)., Results: A total of 138 patients were included in the study, and 12 patients (8.7% (95% CI 4.6-14.7)) were at risk of sarcopenia. The mean SARC-F score was significantly higher in women compared with men (2.1 ± 1.8 vs. 0.9 ± 1.4, respectively; p < 0.001). The majority of patients identified at risk of sarcopenia compared with those not at risk were women (75% vs. 30%, respectively; p = 0.003), had a higher proportion of neuropathy (50% vs. 19%, respectively; p = 0.027), a lower mean MNA ® -SF score (11.6 ± 1.5 vs. 13.0 ± 1.4, respectively; p = 0.001), a lower mean MEDI-quest score (5.2 ± 1.5 vs. 5.9 ± 1, respectively; p = 0.037), and were more inactive (92% vs. 61%, respectively; p = 0.032)., Conclusions: In a sample of older adults with T2D, the risk of sarcopenia was identified in 8.7% (95% CI: 4.6-14.7) of the sample, and the main factors associated were female gender, neuropathy, a lower MNA ® -SF score, low adherence to the Mediterranean diet, and low physical activity.

Published
2023
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45. Fatty acid composition of cholesterol esters reflects dietary fat intake after dietary interventions in a multinational population.

Author

Salamone D, Annuzzi G, Vessby B, Rivellese AA, Bozzetto L, Costabile G, Hermansen K, Uusitupa M, Meyer BJ, and Riccardi G

Subjects
Humans, Dietary Fats pharmacology, Fatty Acids, Monounsaturated, Diet, Fish Oils, Fatty Acids, Cholesterol Esters
Abstract

Background: The effects of different dietary fatty acids (FA) on cardiovascular risk still needs clarification. Plasma lipids composition may be a biomarker of FA dietary intake., Purpose: To evaluate in a composite population the relationships between changes in dietary fat intake and changes in FA levels in serum cholesterol esters., Methods: In a multinational, parallel-design, dietary intervention (KANWU study), dietary intakes (3-day food record) and FA composition of serum cholesterol esters (gas-liquid chromatography) were evaluated at baseline and after 3 months in 162 healthy individuals, randomly assigned to a diet containing a high proportion of saturated (SFA) or monounsaturated (MUFA) fat, with a second random assignment to fish oil or placebo supplements., Results: Main differences in serum lipid composition after the two diets included saturated (especially myristic, C14:0, and pentadecanoic, C15:0) and monounsaturated (oleic acid, C18:1 n-9) FA. C14:0 and C15:0 were related to SFA intake, while C18:1 n-9 was associated with MUFA intake. Fish oil supplementation induced a marked increase in eicosapentaenoic (C20:5 n-3) and docosahexaenoic (C22:6 n-3) acids. After the 3-month intervention, Δ-9 desaturase activity, calculated as palmitoleic acid/palmitic acid (C16:1/C16:0) ratio, was more reduced after the MUFA (0.31±0.10 vs 0.25±0.09, p<0.0001) than SFA diet (0.31±0.09 vs 0.29±0.08, p=0.006), with a statistically significant difference between the two groups (p<0.0001)., Conclusions: This study shows that serum cholesterol ester FA composition can be used during randomized controlled trials as an objective indicator of adherence to experimental diets based on saturated and monounsaturated fat modifications, as well as fish oil supplementation., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2023. Published by Elsevier Inc.)

Published
2023
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46. Legume Consumption and Blood Pressure Control in Individuals with Type 2 Diabetes and Hypertension: Cross-Sectional Findings from the TOSCA.IT Study.

Author

Vitale M, Giosuè A, Sieri S, Krogh V, Massimino E, Rivellese AA, Riccardi G, Vaccaro O, and Masulli M

Subjects
Male, Female, Humans, Blood Pressure, Risk Factors, Cross-Sectional Studies, Vegetables, Diabetes Mellitus, Type 2 complications, Fabaceae, Hypertension
Abstract

Background: Our aims were to evaluate the relationship of habitual legume consumption with blood pressure (BP) control in a large cohort of people with T2D and hypertension, and to investigate whether specific nutritional components of legumes or other foods may contribute to regulate BP levels., Methods: We studied 1897 participants with T2D and hypertension. Dietary habits were assessed through a validated food frequency questionnaire. Sex-specific quartiles of legume consumption were created., Results: Higher legume consumption was associated with a lower intake of energy, carbohydrates, glycaemic load, alcohol, and sodium, and a significantly greater intake of proteins, fat, monounsaturated, polyunsaturated, fibre, potassium, and polyphenols. Significantly lower systolic and diastolic BP values were observed in the highest vs. lowest quartile of legume consumption (132.9 ± 6.7 vs. 137.3 ± 7.0 mmHg, p < 0.001; 78.9 ± 4.1 vs. 81.0 ± 4.2 mmHg, p = 0.002; respectively), as well as the proportion of people meeting the treatment targets (61.3% vs. 37.4% and 71.3% vs. 52.4%, respectively, p < 0.01). This association was independent from other foods whose consumption is associated with the high legume intake., Conclusions: In people with T2D and hypertension, three servings of legumes per week are associated with significantly better BP control. This gives further support to current dietary guidelines in recommending the frequent consumption of legumes, as a "ready-to-use" dietary strategy to achieve optimal BP control.

Published
2023
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47. Triticum vulgare Extract and Polyhexanide (Fitostimoline ® Hydrogel/Fitostimoline ® Plus Gauze) versus Saline Gauze Dressing in Patients with Diabetic Foot Ulcers: Results of a Randomized Controlled Trial.

Author

Della Pepa G, Lombardi G, Gianfrancesco S, Piccolo R, Chirico G, Pellegrino M, Santella L, Tecce N, Volpicelli A, Sollo E, Bozzetto L, Masulli M, Riccardi G, Rivellese AA, and Saldalamacchia G

Abstract

Background: The use of dressings is an essential component of the standard of care for diabetic foot ulcers (DFUs); however, despite the wide variety of dressings available, there is a lack of evidence from head-to-head randomized controlled trials. We evaluated the efficacy and safety of Triticum vulgare extract and polyhexanide (Fitostimoline ® hydrogel/Fitostimoline ® Plus gauze) versus saline gauze dressings in patients with DFUs., Methods: This study involved a monocentric, two-arm, open-label, controlled trial in patients with DFUs (Grades I or II, Stage A or C, based on the Texas classification) randomized to 12 weeks of dressing with Fitostimoline ® hydrogel/Fitostimoline ® Plus gauze or saline gauze. The number of patients with complete healing, the reduction in DFU size, and the presence of local signs and symptoms of the wound and perilesional skin were evaluated every two weeks and at the end of treatment., Results: A total of 40 adult patients were recruited (20 patients in each treatment group). The proportion of patients with complete healing was similar between the two groups (61% vs. 74%, p = 0.495, Fitostimoline ® hydrogel/Fitostimoline ® Plus gauze vs. saline gauze, respectively), without significant differences, as well as the reduction in DFU size. A significant improvement in local signs and symptoms of the wound and signs of perilesional skin in the Fitostimoline ® hydrogel/Fitostimoline ® Plus gauze compared with the saline gauze group was observed., Conclusions: In a clinical setting, the use of Fitostimoline ® hydrogel/Fitostimoline ® Plus gauze dressing in patients with DFUs significantly improves signs and symptoms of the wound and signs of perilesional skin compared with saline gauze dressing with a similar efficacy in terms of wound healing.

Published
2023
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48. Protein and Leucine Intake at Main Meals in Elderly People with Type 2 Diabetes.

Author

Massimino E, Izzo A, Castaldo C, Amoroso AP, Rivellese AA, Capaldo B, and Della Pepa G

Subjects
Male, Aged, Humans, Female, Leucine, Cross-Sectional Studies, Meals, Breakfast, Lunch, Feeding Behavior, Energy Intake, Diabetes Mellitus, Type 2
Abstract

Background: The recommended protein intake for the elderly is 25-30 g at main meals, with at least 2500-2800 mg of leucine at each meal. There is still little evidence regarding the amount and distribution of protein and leucine intake with meals in the elderly with type 2 diabetes (T2D). In this cross-sectional study, we evaluated protein and leucine intake at each meal in elderly patients with T2D., Methods: A total of 138 patients (91 men and 47 women) with T2D, aged 65 years or older, were included. Participants performed three 24-h dietary recalls for the evaluation of their dietary habits and protein and leucine intake at meals., Results: The average protein intake was 0.9 ± 0.2 g/kg body weight/day, and only 23% of patients complied with the recommendations. The average protein intake was 6.9 g at breakfast, 29 g at lunch, and 21 g at dinner. None of the patients reached the recommended protein intake at breakfast; 59% of patients complied with the recommendations at lunch; and 32% at dinner. The average leucine intake was 579 mg at breakfast, 2195 g at lunch, and 1583 mg at dinner. The recommended leucine intake was not reached by any patient at breakfast, by 29% of patients at lunch, and by 13% at dinner., Conclusions: Our data show that, in elderly patients with T2D, the average protein intake is low, particularly at breakfast and dinner, and that leucine intake is remarkably lower than the recommended levels. These data raise the need to implement nutritional strategies capable of increasing protein and leucine intake in the elderly with T2D.

Published
2023
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49. High Amylose Wheat Bread at Breakfast Increases Plasma Propionate Concentrations and Reduces the Postprandial Insulin Response to the Following Meal in Overweight Adults.

Author

Costabile G, Vetrani C, Calabrese I, Vitale M, Cipriano P, Salamone D, Testa R, Paparo L, Russo R, Rivellese AA, Giacco R, and Riccardi G

Subjects
Adult, Female, Humans, Male, Blood Glucose metabolism, Bread, Breakfast, Cross-Over Studies, Glucose, Insulin, Regular, Human, Postprandial Period, Triticum, Amylose administration & dosage, Insulin, Overweight, Propionates blood
Abstract

Background: High amylose starchy foods modulate the postprandial metabolic response in humans. However, the mechanisms of their metabolic benefits and their impact on the subsequent meal have not been fully elucidated., Objective: We aimed to evaluate whether glucose and insulin responses to a standard lunch are influenced by the consumption of amylose-rich bread at breakfast in overweight adults and whether changes in plasma short chain fatty acids (SCFAs) concentrations contribute to their metabolic effects., Methods: Using a randomized crossover design, 11 men and 9 women, BMI 30 ± 3 kg/m 2 , 48 ± 19 y, consumed at breakfast 2 breads made with high amylose flour (HAF): 85%-HAF (180 g) and 75%-HAF (170 g), and control bread (120 g) containing 100% conventional flour. Plasma samples were collected at fasting, 4 h after breakfast, and 2 h after a standard lunch to measure glucose, insulin, and SCFA concentrations. ANOVA posthoc analyses were used for comparisons., Results: Postprandial plasma glucose responses were 27% and 39% lower after breakfasts with 85%- and 70%-HAF breads than control bread (P = 0.026 and P = 0.003, respectively), with no difference after lunch. Insulin responses were not different between the 3 breakfasts, whereas there was a 28% lower response after the lunch following breakfast with 85%-HAF bread than the control (P = 0.049). Propionate concentrations increased from fasting by 9% and 12% 6 h after breakfasts with 85%- and 70%-HAF breads and decreased by 11% with control bread (P < 0.05). At 6 h after breakfast with 70%-HAF bread, plasma propionate and insulin were inversely correlated (r = -0.566; P = 0.044)., Conclusions: Amylose-rich bread reduces the postprandial glucose response after breakfast and insulin concentrations after the subsequent lunch in overweight adults. This second meal effect may be mediated by the elevation of plasma propionate due to intestinal fermentation of resistant starch. High amylose products could be a promising tool in a dietary prevention strategy for type 2 diabetes., This Trial Was Registered at Clinical Trial Registry as: NCT03899974 (https://www., Clinicaltrials: gov/ct2/show/NCT03899974)., (Copyright © 2022 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)

Published
2023
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50. Evaluation of eating habits by 7-day food record: web-PC vs. traditional paper format.

Author

Vitale M, Bruno V, D'Abbronzo G, Rivellese AA, Bozzetto L, Scidà G, and Annuzzi G

Subjects
Adult, Female, Humans, Male, Alcohol Drinking, Cross-Over Studies, Diet, Diet Records, Eating, Energy Intake, Reproducibility of Results, Surveys and Questionnaires, Feeding Behavior, Food
Abstract

The aim of this study was to evaluate the validity of a web-based 7-day food-record using METADIETA-web link (Meteda s.r.l.) - a professional software used in nutritional practice and research - compared with the traditional paper format. Twenty-six healthy adults of both sexes were recruited in this cross-over study based on the number coming from the sample size calculation, and randomly assigned to start with METADIETA-web or traditional 7-Day Food-Diary. All the 7-day food-diaries were recorded in the Metadieta-software. The System Usability Scale (SUS) questionnaire was administered to evaluate the participants' preferences in terms of usability, acceptability, and feasibility. Differences in energy intake, nutrient composition, and SUS between the digital and traditional modalities were evaluated. Energy and nutrients were not significantly different between the two methods with a variation <15%, with alcohol intake showing the strongest relation (0.1% variation). The Interclass Correlation Coefficient showed a grade of consistency between the two methods excellent for alcohol, good for proteins, carbohydrates, and fibre, moderate for energy and saturated fat, and poor for total fat and cholesterol. SUS suggested that the web-based platform was in general well accepted, but highlighted some inconsistencies and complexity compared to the written food diary. The web-based 7-day food-record may allow an accurate and quicker analysis of food timing than conventional approaches, seeming reliable for energy and macronutrient composition, making it a potentially attractive tool for nutritional research. However, the reported inconsistencies and complexity must be considered and addressed.

Published
2023
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