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1. Burden of cardiovascular disease in a large contemporary cohort of patients with heterozygous familial hypercholesterolemia

Author: Jean Ferrières, Michel Farnier, Eric Bruckert, Alexandre Vimont, Vincent Durlach, Emile Ferrari, Antonio Gallo, Franck Boccara, Dorota Ferrières, Sophie Béliard, Denis Angoulvant, Karine Aouchiche, Sophie Beliard, Bertrand Cariou, Valérie Carreau, Alain Carrie, Sybil Charrieres, Yves Cottin, Mathilde Di Filippo, Caroline Dourmap, Pierre-Henri Ducluzeau, Dorota Ferrieres, Jean Ferrieres, Regis Hankard, Jocelyn Inamo, Olga Kalmykova, Michel Krempf, Julie Lemale, Philippe Moulin, François Paillard, Noel Peretti, Agnes Perrin, Alain Pradignac, Yann Pucheu, Jean Pierre Rabes, Rachel Reynaud, Vincent Rigalleau, François Schiele, Ariane Sultan, Patrick Tounian, René Valero, Bruno Verges, Cecile Yelnik, and Olivier Ziegler
Subjects: Heterozygous familial hypercholesterolemia, Registry, Incidence, Recurrence, Lipid-lowering treatment, Prognosis, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background and aims: Heterozygous familial hypercholesterolemia (HeFH) is increasingly better diagnosed and treatments can improve the cardiovascular prognosis. We evaluated the long-term cardiovascular risk of HeFH using the French REgistry of Familial hypERCHOLesterolemia (REFERCHOL). Methods: We studied HeFH patients diagnosed genetically and clinically by the Dutch Lipid Clinic Network (DLCN) criteria in all lipid clinics across the country and their 5-year risk of cardiovascular events (all fatal and non-fatal acute coronary, cerebral and peripheral arterial disease events, aortic valve replacement surgery) using the French national health data system. Results: The database comprised 3202 individuals, 2010 (62.8%) with genetically verified HeFH and 1192 (37.2%) a DLCN score ≥6. Of these individuals, 2485 (77.6%) were in primary prevention and 717 (22.4%) in secondary prevention. The incidence of cardiovascular events was 24.58 per 1000 person-years for the overall sample, 19.15 in primary prevention and 43.40 in secondary prevention. The incidence of myocardial infarction, cerebral infarction and death was 16.32 per 1000 person-years for the overall sample, 12.93 in primary prevention and 28.08 in secondary prevention. The incidence of aortic valve replacement was 1.78 per 1000 person-years. In the overall sample, at inclusion, 41% were not treated for LDL cholesterol, 48% of these in primary prevention and 20% in secondary prevention and high-dose statins were used by only 24% of individuals, 15% of these in primary prevention and 45% in secondary prevention. Conclusions: The incidence of cardiovascular events in HeFH is high and lipid-lowering treatment is far from optimal. The cardiovascular risk of HeFH is underestimated and patients are inadequately treated.
Published: 2022
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2. Développement des médicaments en pédiatrie : défis existants et recommandations

Author: Florentia Kaguelidou, Maria Ouèdraogo, Jean-Marc Treluyer, Claire Le Jeunne, Maxime Annereau, Patricia Blanc, Serge Bureau, Stéphane Ducassou, Béatrice Fiquet, Florence Flamein, Ségolène Gaillard, Regis Hankard, Vincent Laugel, Corinne Laurent, Corinne Levy, Thierry Marquet, Michel Polak, Aurélie Portefaix, and Gilles Vassal
Subjects: Pharmacology (medical)
Published: 2023
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3. Paediatric drug development and evaluation: Existing challenges and recommendations

Author: Florentia, Kaguelidou, Maria, Ouèdraogo, Jean-Marc, Treluyer, Claire, Le Jeunne, Maxime, Annereau, Patricia, Blanc, Serge, Bureau, Stéphane, Ducassou, Béatrice, Fiquet, Florence, Flamein, Ségolène, Gaillard, Regis, Hankard, Vincent, Laugel, Corinne, Laurent, Corinne, Levy, Thierry, Marquet, Michel, Polak, Aurélie, Portefaix, and Gilles, Vassal
Subjects: Pharmacology (medical)
Abstract: Despite various international regulatory initiatives over the last 20 years, many challenges remain in the field of paediatric drug development and evaluation. Indeed, drug research and development is still focused essentially on adult indications, thereby excluding many paediatric patients, limiting the feasibility of trials and favouring competing developments. Off-label prescribing persists and the development of age-appropriate dosage forms for children remains limited. Against this background, the members of this panel (TR) recommend the launch of multi-partner exchange forums on specific topics in order to focus new drug research and development on the real, unmet medical needs of children and adolescents, and in keeping with the underlying mechanisms of action. Scientific information sharing and cooperation between stakeholders are also essential for defining reference evaluation methods in each medical field. These forums can be organised through existing paediatric facilities and research networks at the French and European level. The latter are specifically dedicated to paediatric research and can facilitate clinical trial implementation and patient enrolment. Moreover, specific grants and public/private partnerships are still needed to support studies on the repositioning of drugs in paediatric indications, and pharmacokinetic studies aimed at defining appropriate dosages. The development of new pharmaceutical forms, better suited for paediatric use, and the promotion of resulting innovations will stimulate future investments. Initiatives to gather observational safety and efficacy data following off-label and/or derogatory early access should also be encouraged to compensate for the lack of information available in these situations. Finally, the creation of Ethics Committees (EC) with a specific "mother-child" advisory expertise should be promoted to ensure that the current regulation (Jardé law in France) is implemented whilst also taking into account the paediatric specificities in medical trials.
Published: 2023
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4. Maternal Inheritance of Familial Hypercholesterolemia Gene Mutation Predisposes to Coronary Atherosclerosis as Assessed by Calcium Score in Adulthood

Author: Florian Mourre, Roch Giorgi, Antonio Gallo, Franck Boccara, Eric Bruckert, Alain Carrié, Regis Hankard, Jocelyn Inamo, Sandrine Laboureau, Philippe Moulin, René Valéro, Sophie Béliard, Denis Angoulvant, Sophie Beliard, Bertrand Cariou, Valérie Carreau, Alain Carrie, Sybil Charrieres, Yves Cottin, Mathilde Di Filippo, Pierre Henri Ducluzeau, Sonia Dulong, Vincent Durlach, Michel Farnier, Emile Ferrari, Dorota Ferrieres, Jean Ferrieres, Olga Kalmykova, Michel Krempf, Julie Lemale, François Paillard, Noel Peretti, Agnes Perrin, Alain Pradignac, Jean Pierre Rabes, Vincent Rigalleau, François Schiele, Ariane Sultan, Patrick Tounian, René Valero, Bruno Verges, Cecile Yelnik, Olivier Ziegler, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Nutrition, croissance et cancer (U 1069) (N2C), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), and Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
Subjects: [SDV]Life Sciences [q-bio], hyperlipidemia, maternal inheritance, risk factors, atherosclerosis, Cardiology and Cardiovascular Medicine, cardiovascular diseases
Abstract: Background: Animal studies have demonstrated that fetal exposure to high maternal cholesterol levels during pregnancy predisposes to aortic atheroma in the offspring. In humans, little is known about the consequences of this exposure on the development of atherosclerotic cardiovascular disease later in life. We wanted to assess whether maternal/paternal inheritance of familial hypercholesterolemia (FH) gene mutation could be associated with subclinical coronary atherosclerosis. Methods: We retrospectively included 1350 patients, followed in the French registry of FH, with a documented genetic diagnosis. We selected 556 age- and sex-matched pair of patients based on the sex of the parents who transmitted the FH gene mutation, free of coronary cardiovascular event, and with a subclinical coronary atherosclerosis evaluation assessed using coronary artery calcium (CAC) score. We performed univariate and multivariate analysis to assess the individual effect of parental inheritance of the FH gene mutation on the CAC score. Results: In the whole population, patients with maternal inheritance of FH gene mutation (n=639) less frequently had a family history of premature cardiovascular events (27.7% versus 45%, P P =0.02) than those with paternal inheritance (n=711). There was no difference in the prevalence of cardiovascular events between the two groups. In the matched subgroup, maternal inheritance was significantly associated with an increase in CAC score value by 86% (95% CI, 23%–170%; P =0.003), a 1.81-fold risk of having a CAC score ≥100 Agatston units (95% CI, 1.06–3.11; P =0.03), and a 2.72-fold risk of having a CAC score ≥400 Agatston units (95% CI, 1.39–5.51; P =0.004) when compared with paternal inheritance in multivariate analysis. Conclusions: Maternal inheritance of FH gene mutation was associated with more severe subclinical coronary atherosclerosis assessed by CAC score and may be considered as a potential cardiovascular risk factor.
Published: 2023
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5. The Added Value of Coronary Calcium Score in Predicting Cardiovascular Events in Familial Hypercholesterolemia

Author: Antonio Gallo, Leopoldo Pérez de Isla, Sybil Charrière, Alexandre Vimont, Rodrigo Alonso, Ovidio Muñiz-Grijalvo, José L. Díaz-Díaz, Daniel Zambón, Philippe Moulin, Eric Bruckert, Pedro Mata, Sophie Béliard, Denis Angoulvant, Sophie Beliard, Franck Boccara, Bertrand Cariou, Valérie Carreau, Alain Carrie, Sybil Charrieres, Yves Cottin, Mathilde Di Filippo, Pierre Henri Ducluzeau, Sonia Dulong, Vincent Durlach, Michel Farnier, Emile Ferrari, Dorota Ferrieres, Jean Ferrieres, Philippe Giral, Sophie Gonbert, Regis Hankard, Jocelyn Inamo, Olga Kalmykova, Michel Krempf, Julie Lemale, François Paillard, Noel Peretti, Agnes Perrin, Alain Pradignac, Jean Pierre Rabes, Vincent Rigalleau, François Schiele, Ariane Sultan, Patrick Tounian, René Valero, Bruno Verges, Cecile Yelnik, Olivier Ziegler, Rocío Aguado, Ma Pilar Álvarez-Baños, Rosa Argüeso, Francisco Arrieta, Miguel Ángel Barba, Marta Casañas, José María Cepeda, Raimundo De Andrés, Gonzalo Díaz-Soto, Jose Luis Díaz-Diaz, Marta Dieguez, Ceferino Faedo, Francisco Fuentes, Juan A. Garrido, Aurora González, Pablo González-Bustos, Ma Dolores Mañas, Marta Mauri, Juan Diego Mediavilla, Alfredo Michán, Pablo Miramontes, Ovidio Muñiz, Leire Pérez, Leopoldo Perez De Isla, Xavier Pintó, Manuel J. Romero, Patricia Rubio, Juan F. Sánchez Muñoz-Torrero, Jose I. Vidal-Pardo, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire d'Imagerie Biomédicale (LIB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain] (IdISSC), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Public Health Expertise [Paris, France], Hospital Universitario Virgen del Rocío [Sevilla], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Laboratoire d'Imagerie Biomédicale [Paris] (LIB), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Hospital Abente y Lago, Fundación Hipercolesterolemia Familiar, and ANR-16-RHUS-0007,CHOPIN,CHOPIN(2016)
Subjects: Adult, Male, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Coronary Artery Disease, Disease, Familial hypercholesterolemia, 030204 cardiovascular system & hematology, Risk Assessment, Sudden death, Cohort Studies, Hyperlipoproteinemia Type II, risk prediction, 03 medical and health sciences, 0302 clinical medicine, cardiovascular disease, genetic disease, Predictive Value of Tests, Risk Factors, Interquartile range, Internal medicine, Humans, Medicine, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, Vascular Calcification, Stroke, coronary artery calcium, ComputingMilieux_MISCELLANEOUS, familial hypercholesterolemia, business.industry, Proportional hazards model, nutritional and metabolic diseases, Middle Aged, Atherosclerosis, medicine.disease, 3. Good health, Coronary Calcium Score, Cardiology, Calcium, Cardiology and Cardiovascular Medicine, business, coronary imaging, Cohort study
Abstract: International audience; ObjectivesThis study aimed at investigating the additional contribution of coronary artery calcium (CAC) score to SAFEHEART (Spanish Familial Hypercholesterolemia Cohort Study) risk equation (SAFEHEART-RE) for cardiovascular risk prediction in heterozygous familial hypercholesterolemia (HeFH).BackgroundCommon cardiovascular risk equations are imprecise for HeFH. Because of the high phenotype variability of HeFH, CAC score could help to better stratify the risk of atherosclerotic cardiovascular disease (ASCVD).MethodsREFERCHOL (French Registry of Familial Hypercholesterolemia) and SAFEHEART are 2 ongoing national registries on HeFH. We analyzed data from primary prevention HeFH patients undergoing CAC quantification. We used probability-weighted Cox proportional hazards models to estimate HRs. Area under the receiver-operating characteristic curve (AUC) and net reclassification improvement (NRI) were used to compare the incremental contribution of CAC score when added to the SAFEHEART-RE for ASCVD prediction. ASCVD was defined as coronary heart disease, stroke or transient ischemic attack, peripheral artery disease, resuscitated sudden death, and cardiovascular death.ResultsWe included 1,624 patients (mean age: 48.5 ± 12.8 years; men: 45.7%) from both registries. After a median follow-up of 2.7 years (interquartile range: 0.4-5.0 years), ASCVD occurred in 81 subjects. The presence of a CAC score of >100 was associated with an HR of 32.05 (95% CI: 10.08-101.94) of developing ASCVD as compared to a CAC score of 0. Receiving-operating curve analysis showed a good performance of CAC score alone in ASCVD prediction (AUC: 0.860 [95% CI: 0.853-0.869]). The addition of log(CAC + 1) to SAFEHEART-RE resulted in a significantly improved prediction of ASCVD (AUC: 0.884 [95% CI: 0.871-0.894] for SAFEHEART-RE + log(CAC + 1) vs AUC: 0.793 [95% CI: 0.779-0.818] for SAFEHEART-RE; P < 0.001). These results were confirmed also when considering only hard cardiovascular endpoints. The addition of CAC score was associated with an estimated overall net reclassification improvement of 45.4%.ConclusionsCAC score proved its use in improving cardiovascular risk stratification and ASCVD prediction in statin-treated HeFH.
Published: 2021
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6. Nutritional Assistance by Software Improves Surgical Outcomes of Elective Colorectal Surgery

Author: Aurélie Maignan, Remy Le Huu Nho, Diane Mege, Igor Sielezneff, Cecilia Frasconi, Nicolas Pirro, Regis Hankard, Laurence Boiron, Antonio Iannelli, Jacques di Costanzo, Théophile Guilbaud, Caroline Rossi, Mehdi Ouaissi, and Loundou Anderson
Subjects: 03 medical and health sciences, medicine.medical_specialty, 0302 clinical medicine, business.industry, 030220 oncology & carcinogenesis, General surgery, medicine, Nutrition support, 030211 gastroenterology & hepatology, Surgery, business, Colorectal surgery
Abstract: Objective The present study analyzes nutrition support in a group of patients undergoing colorectal surgery managed by nutritional requirement software compared to a group of consecutive patients undergoing colorectal surgery with conventional nutrition Materials and Methods A total of 485 patients were treated between January 2000 and January 2013 with colorectal resection. Outcomes (mortality, morbidity according to Clavien classification, length of hospital stay, type of colorectal disease) in a group of patients who received nutrition support through software (SG) were compared to those in a previous series, control group (CG) with conventional nutrition support Results Of the patients, 59.6% were men and the median age of the population was 68.2 years (range, 19–95 years), with no difference between the 2 groups. There were significantly more malnourished patients in the SG group (SG 63.8% versus 45.2% CG; P < 0.0001). The overall mortality was 2.1% lower in the SG group, but without a significant difference (SG 0.7% versus 2.7% CG). There were more severe stage III to IV complications according to Clavien classification in the SG group (SG 10.7 GC versus 17% NS), with significantly greater collections (SG 8% versus 16.9% CG; P = 0.015) and greater anastomotic leaks (SG 4% versus 13.9% CG; P < 0.001). The median hospital stay was lower in the SG group (SG 12 days versus 15 days CG; P = 0.049). Conclusion The proposed software could contribute to optimizing the strategy of nutritional support in hospitalized patients.
Published: 2019
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7. SAFEHEART risk-equation and cholesterol-year-score are powerful predictors of cardiovascular events in French patients with familial hypercholesterolemia

Author: Antonio Gallo, Sybil Charriere, Alexandre Vimont, M. John Chapman, Denis Angoulvant, Franck Boccara, Bertrand Cariou, Valérie Carreau, Alain Carrié, Eric Bruckert, Sophie Béliard, Sophie Beliard, Alain Carrie, Yves Cottin, Mathilde DI. Filippo, Sonia Dulong, Vincent Durlach, Michel Farnier, Emile Ferrari, Dorota Ferrieres, Jean Ferrieres, Philippe Giral, Sophie Gonbert, Regis Hankard, Jocelyn Inamo, Olga Kalmykova, Michel Krempf, Philippe Moulin, François Paillard, Noel Peretti, Agnes Perrin, Jean Pierre Rabes, Ariane Sultan, Patrick Tounian, René Valero, Bruno Verges, Cecile Yelnik, Olivier Ziegler, Inserm UMR1069, Nutrition, croissance et cancer (U 1069) (N2C), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire catalyse et spectrochimie (LCS), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-École Nationale Supérieure d'Ingénieurs de Caen (ENSICAEN), Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Cardiologie (CHU Trousseau, Tours), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre recherche en CardioVasculaire et Nutrition (C2VN), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)-Institut National de la Recherche Agronomique (INRA), Centre de Recherche Saint-Antoine (CR Saint-Antoine), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Service d'endocrinologie-métabolisme [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), CHU Pitié-Salpêtrière [AP-HP], Station d'Amélioration Génétique des Animaux (SAGA), Institut National de la Recherche Agronomique (INRA), Centre Hospitalier Universitaire de Lyon, Service de Cardiologie [CHU de Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Pôle Thoracique Cardiovasculaire et Neurologique, Hôpital Robert Debré, Point médical (Dijon), Hôpital Pasteur [Nice] (CHU), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Istituto di Scienze degli Alimenti e della Nutrizione, Università Cattolica del Sacro Cuore, Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Centre d' investigation clinique-plurithématique du CHU de Poitiers, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service de cardiologie, Hôpital Pierre Zobda-Quitman [CHU de la Martinique], CHU de la Martinique [Fort de France]-CHU de la Martinique [Fort de France], Samara State Technical University, Biologie et physiopathologie intestinales. Pharmacologie nutritionnelle, Université de Nantes (UN)-IFR26-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Hôpital Femme Mère Enfant, Laboratoire Interuniversitaire des Systèmes Atmosphériques (LISA (UMR_7583)), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut national des sciences de l'Univers (INSU - CNRS)-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Service de gastro-entérologie [CHU Trousseau], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Nutrition, obésité et risque thrombotique (NORT), Aix Marseille Université (AMU)-Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Endocrinologie, Diabétologie et Maladies Métaboliques (CHU de Dijon), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Jeanne d'Arc, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours, Institut national des sciences de l'Univers (INSU - CNRS)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Centre National de la Recherche Scientifique (CNRS), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Hospices Civils de Lyon (HCL), Public Health Expertise [Paris, France], Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université (SU), Service d'Endocrinologie, Métabolisme et Prévention des Maladies Cardio-vasculaires [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de Cardiologie [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Unité de recherche de l'institut du thorax (ITX-lab), Service d'endocrinologie, diabète, maladies métaboliques [Hôpital de la Conception - APHM], Aix Marseille Université (AMU), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), French REgistry of Familial hypERCHOLesterolemia (REFERCHOL) investigators, ANR-16-RHUS-0007,CHOPIN,CHOPIN(2016), Gestionnaire, Hal Sorbonne Université, CHOPIN - - CHOPIN2016 - ANR-16-RHUS-0007 - RHUS - VALID, Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service d’Endocrinologie, Métabolisme et Prévention des Risques Cardio-Vasculaires [CHU Pitié-Salpêtrière], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)
Subjects: cardiovascular risk, 0301 basic medicine, medicine.medical_specialty, cardiovascular risk equation, Population, Familial hypercholesterolemia, 030204 cardiovascular system & hematology, Risk Assessment, Cohort Studies, Hyperlipoproteinemia Type II, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, medicine, Humans, education, ComputingMilieux_MISCELLANEOUS, Risk equation, [SDV.MHEP.EM] Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, Entire population, education.field_of_study, familial hypercholesterolemia, business.industry, Cholesterol, External validation, Cholesterol, LDL, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, medicine.disease, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, 030104 developmental biology, cholesterol-year-score, chemistry, Cardiovascular Diseases, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Clinical diagnosis, primary cardiovascular prevention, Cohort, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Cardiology and Cardiovascular Medicine, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition
Abstract: Background and aims Patients with heterozygous familial hypercholesterolemia (HeFH) present elevated cardiovascular (CV) risk. Current CV risk stratification algorithms developed for the general population are not adapted for heFH patients. It is therefore of singular importance to develop and validate CV prediction tools, which are dedicated to the HeFH population. Methods Our first objective was to validate the Spanish SAFEHEART-risk equation (RE) in the French HeFH cohort (REFERCHOL), and the second to compare SAFEHEART-RE with the low-density-lipoprotein-cholesterol (LDL-C)-year-score for the prediction of CV events in the HeFH French population. Results We included HeFH (n = 1473) patients with a genetic or clinical diagnosis (DLCN score ≥8). Among them, 512 patients with a 5-year follow-up were included to validate the 5 year-CV-RE. A total of 152 events (10.3%) occurred in the entire population of 1473 patients during a mean follow-up of 3.9 years. Over the five-year follow-up, non-fatal CV events occurred in 103 patients (20.2%). Almost all the parameters used in the SAFEHEART-RE were confirmed as strong predictors of CV events in the REFERCHOL cohort. The C-statistic revealed a satisfactory performance of both the SAFEHEART-RE and LDL-C-year-scores in predicting CV events for all the patients (primary and secondary prevention) (C-index 0.77 and 0.70, respectively) as well as for those in primary prevention at inclusion (C-index 0.78 and 0.77, respectively). Conclusions This analysis represents the first external validation of the SAFEHEART-RE and demonstrated that both SAFEHEART-RE and the LDL-C-year-score are good predictors of CV events in primary prevention HeFH patients.
Published: 2020
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8. To which extent social withdrawal at the age of 1 year is associated with IQ at 5–6 years old? Results of the EDEN mother–child cohort

Author: Marie Aline Charles, Jonathan Bernard, Hugo Peyre, Regis HANKARD, Blandine De Lauzon-Guillain, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Johanna Lepeule, Antoine Guedeney, and Barbara Heude
Subjects: Male, medicine.medical_specialty, Social withdrawal, Intelligence, Developmental psychology, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Developmental and Educational Psychology, Child and adolescent psychiatry, medicine, Humans, 0501 psychology and cognitive sciences, Longitudinal Studies, Child, Social Behavior, Association (psychology), Motor skill, Intelligence quotient, 05 social sciences, General Medicine, Mother-Child Relations, Psychiatry and Mental health, Distress, Child, Preschool, Pediatrics, Perinatology and Child Health, Cohort, Female, Psychology, 030217 neurology & neurosurgery, 050104 developmental & child psychology, Cohort study
Abstract: The present study aims to determine to which extent social withdrawal at 1 year is associated with the child's IQ at the end of the preschool period. Children (N = 1045) from the EDEN mother-child cohort were assessed for social withdrawal behaviours at 1 year by trained midwives using the Alarm Distress BaBy (ADBB) scale. Midwives also examined infants' language and motor development at 1 year. At the age 5-6 years, IQ scores were based on the WPPSI-III. Linear regression models were used to determine the association between IQ and ADBB, adjusted for a broad range of pre- and postnatal environmental factors and for language and motor skills scores at 1 year. After adjusting for environmental factors, children with social withdrawal at 1 years (ADBB ≥5; N = 195) had significantly lower IQ scores at 5-6 years (-2.81 IQ points; p value 0.007) compared to children without social withdrawal (ADBB
Published: 2017
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9. Postpartum psychological distress associated with anal incontinence in the EDEN mother–child cohort: Postpartum psychological distress and anal incontinence

Author: Marie Aline Charles, Jonathan Bernard, Regis HANKARD, Blandine De Lauzon-Guillain, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Johanna Lepeule, Barbara Heude, Patricia Dargent-Molina, CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), We acknowledge all funding sources for the EDEN study: FRM (Fondation pour la Recherche Médicale), INSERM, Ministère de la Recherche, Université Paris Sud (XI), ANR (Agence Nationale de la Recherche), IRESP (Institut de Recherche en Santé Publique), AFSSET (Agence Française pour la Surveillance et la Sécurité de l’Environnement et du Travail), Santé Publique France (Institut National Pour l’Education et la Santé, Institut National de Veille Sanitaire), DGS (Direction Générale de la Santé), ALFEDIAM (Association de Langue Française pour l'Etude du Diabète et du Métabolisme), MGEN (Mutuelle générale de l’Education Nationale), Nestlé., EDEN Mother-Child Cohort Study Group : Collaborators (27) Annesi-Maesano I, Bernard JY, Botton J, Charles MA, Dargent-Molina P, de Lauzon-Guillain B, Ducimetière P, de Agostini M, Foliguet B, Forhan A, Fritel X, Germa A, Goua V, Hankard R, Heude B, Kaminski M, Larroque B, Lelong N, Lepeule J, Magnin G, Marchand L, Nabet C, Pierre F, Slama R, Saurel-Cubizolles MJ, Schweitzer M, Thiebaugeorges O., Service de gynécologie et obstétrique [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), and EDEN Mother-Child Cohort Study Group : Annesi-Maesano I, Bernard JY, Botton J, Charles MA, Dargent-Molina P, de Lauzon-Guillain B, Ducimetière P, de Agostini M, Foliguet B, Forhan A, Fritel X, Germa A, Goua V, Hankard R, Heude B, Kaminski M, Larroque B, Lelong N, Lepeule J, Magnin G, Marchand L, Nabet C, Pierre F, Slama R, Saurel-Cubizolles MJ, Schweitzer M, Thiebaugeorges O.
Subjects: Adult, Postpartum depression, medicine.medical_specialty, Population, Breastfeeding, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Psychological Distress, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, medicine, cohort study, Flatulence, Humans, postpartum, education, Depression (differential diagnoses), education.field_of_study, Pregnancy, 030219 obstetrics & reproductive medicine, Obstetrics, business.industry, anal incontinence, Obstetrics and Gynecology, Puerperal Disorders, medicine.disease, Mental health, Antidepressive Agents, 3. Good health, Breast Feeding, Multivariate Analysis, Cohort, depression, Female, France, business, Fecal Incontinence, Cohort study
Abstract: Objective To estimate the prevalence of flatus-only and faecal incontinence, to describe their risk factors and to analyse the association between anal incontinence and psychological distress over the first year postpartum. Design Cohort study from pregnancy to 12 months postpartum. Setting Two university hospital maternity wards in France. Population A total of 2002 pregnant women were recruited between 2003 and 2006. Data on anal incontinence were available for the 1632 women who comprise the sample for analysis. Methods Women were enrolled during pregnancy. A postal questionnaire was sent at 4 and 12 months postpartum. Main outcome measures Anal (flatus-only and faecal) incontinence was assessed at 4 months postpartum. Mental health was assessed at 4 and 12 months postpartum by the Edinburgh Postpartum Depression Scale (EPDS) and use of antidepressant drugs as well as by self-rated mental health. Results At 4 months postpartum, the prevalence for flatus-only incontinence was 14.4% and for faecal incontinence 1.7%; multivariate analysis, restricted to women reporting no anal incontinence before the index pregnancy, showed that continuing breastfeeding at 4 months was related to a higher risk of de novo postpartum anal incontinence (OR = 2.23). Women who reported anal incontinence at 4 months were more frequently depressed (EPDS ≥10 or antidepressant use) at 12 months postpartum: 36.0% of those with faecal incontinence were depressed, 23.3% of those with flatus-only incontinence and only 14.8% of the continent women. Conclusion Postnatal faecal incontinence was rare but associated with poorer maternal mental health. Postnatal screening should be encouraged, and psychological support offered. Tweetable abstract Postnatal faecal incontinence was associated with depression; postnatal screening should be encouraged and psychological support offered.
Published: 2019
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10. Recherche en pédiatrie (2) : le consentement en pratique

Author: Michel Tsimaratos, Christele GRAS-LE GUEN, Emmanuelle Rochette, Regis HANKARD, Frederic Gottrand, Michael Fayon, Evelyne Jacqz-Aigrain, Laurent BEGHIN, and Dominique Deplanque
Subjects: Informed consent, Pediatric research, education, Pediatrics, Perinatology and Child Health, Legal guardian, Cultural context, MEDLINE, Frame (artificial intelligence), Engineering ethics, Context (language use), Psychology, Domain (software engineering)
Abstract: Ethical and regulatory documents frame informed consent in pediatric research; their application is obligatory but may be complex. In this specific context, pediatric investigators have a central ethical role to play to ensure the strict respect of regulatory and ethical requirements adapted to the French legal, social, and cultural context as well as good clinical practices. This article attempts to shed light on the considerations that can allow researchers to come to terms with industrial and institutional demands while responding to the needs of patients, particularly in the domain of pediatric research.
Published: 2015
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11. Recherche en pédiatrie (1) : dispositions juridiques relatives au consentement

Author: Michel Tsimaratos, Christele GRAS-LE GUEN, Emmanuelle Rochette, Regis HANKARD, Frederic Gottrand, Michael Fayon, Evelyne Jacqz-Aigrain, Laurent BEGHIN, and Dominique Deplanque
Subjects: medicine.medical_specialty, Pediatrics, Pediatric research, MEDLINE, Context (language use), Minor (academic), Ethical standards, humanities, Clinical trial, Family medicine, Pediatrics, Perinatology and Child Health, medicine, Parental consent, health care economics and organizations
Abstract: In pediatric research, the patient is legally a minor and therefore protected by law. Research can only be conducted after parental consent and patient assent have been obtained. In this context, this review discusses the historical events and documents related to all ethical precautions and obligations. It also underlines that physicians shall respect all legal measures, but that individual involvement must comply with ethical standards while taking into account issues particular to pediatric research related to parental consent and child assent to clinical trials.
Published: 2015
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12. Postnatal Weight and Height Growth Modeling and Prediction of Body Mass Index as a Function of Time for the Study of Growth Determinants

Author: Marie Aline Charles, Remy Slama, Jérémie Botton, Regis HANKARD, Blandine De Lauzon-Guillain, Pauline Scherdel, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Johanna Lepeule, Barbara Heude, and Alice Germa
Subjects: Male, Gerontology, Growth data, Birth weight, Medicine (miscellaneous), Health outcomes, Body Mass Index, Child Development, Pregnancy, Statistics, Birth Weight, Humans, Mathematics, Nutrition and Dietetics, Body Weight, Infant, Newborn, Infant, Reproducibility of Results, Growth model, Random effects model, Body Height, Nonlinear Dynamics, Child, Preschool, Nonlinear model, Cohort, Female, Body mass index
Abstract: Weight, height and body mass index (BMI) growth trajectories have been associated with several chronic diseases in later life. Our aim was to describe a method to model individual weight and height growth curves during infancy and to show how it can be used to study their determinants and relationships with later health outcomes as well as to predict BMI trajectories. In the EDEN mother-child cohort, we collected 17 measurements of weight and 16 of length/height per child between birth and 3 years of age in 1,900 infants from their health care booklet and during the study clinical examinations at 1 and 3 years; 1,436 (76%) had at least 1 measurement between 2 and 3 years. We fitted individual weight and height growth trajectories using the Jenss nonlinear model including random effects using the ‘SAEMIX' package (R software). We studied whether individual growth model parameters were associated with gender in one- and two-step approaches. We indirectly calculated BMI increase against time from both weight and height growth models combined and compared the fit with a direct multilevel spline model. By modeling observed growth data, we homogenized the data in terms of number and age of measurements and were able to calculate other specific parameters as growth velocities.
Published: 2014
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13. Perinatal risk factors and social withdrawal behaviour

Author: Marie Aline Charles, Regis HANKARD, Marie-Josephe Saurel-Cubizolles, Antoine Guedeney, Barbara Heude, and Laetitia Marchand-Martin
Subjects: Male, Parents, Pediatrics, medicine.medical_specialty, Longitudinal study, Social withdrawal, Birth weight, Perinatal risk, Gestational Age, Child Behavior Disorders, Risk Factors, Developmental and Educational Psychology, medicine, Child and adolescent psychiatry, Humans, Longitudinal Studies, Parent-Child Relations, Social Behavior, Smoking, Infant, Gestational age, General Medicine, Psychiatry and Mental health, Low birth weight, Editorial, Infant Behavior, Pediatrics, Perinatology and Child Health, Cohort, Female, medicine.symptom, Psychology, Maternal Age
Abstract: The objectives of the study were (1) to assess prevalence of social withdrawal behaviour in infants aged 12 months included in the French Perinatal Risk Factor Study Eden; (2) To study the correlation between relational withdrawal and several perinatal and parental factors assessed in the EDEN study. A longitudinal study using the ADBB scale was conducted within the Eden Cohort in the year 2008. 1,586 infants were included in the study. Fourteen percent of the children who had an ADBB assessment had a score at 5 and over on the ADBB, a scale designed to assess social withdrawal behaviour at age 0-24 months. Social withdrawal at 12 months was associated with low birth weight, low gestational age and with intra uterine growth retardation. Social withdrawal was independently associated with several maternal and paternal risk factors. The level of social withdrawal behaviour increased with a score of maternal difficulties. This study on a large longitudinally followed volunteer sample demonstrate a clear association of social withdrawal behaviour at age one with low birth weight and preterm birth, possibly mediated by parental vulnerabilities. Social withdrawal behaviour seems to be an important alarm signal to detect early on particularly in premature and small for date babies.
Published: 2012
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14. Association of postpartum depressive symptoms and urinary incontinence. A cohort study

Author: Marie Aline Charles, Jonathan Bernard, Regis HANKARD, Blandine De Lauzon-Guillain, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Barbara Heude, Alice Germa, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d' investigation clinique-plurithématique du CHU de Poitiers, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service de gynécologie et obstétrique [Poitiers], Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ) - Université Paris-Sud - Paris 11 (UP11) - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Paul Brousse - Institut National de la Santé et de la Recherche Médicale (INSERM), CHU de Poitiers, Université de Poitiers - CHU de Poitiers, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS), Institut National de la Recherche Agronomique (INRA) - Université Paris Diderot - Paris 7 (UPD7) - Université Paris Descartes - Paris 5 (UPD5) - Université Paris 13 - Institut National de la Santé et de la Recherche Médicale (INSERM), Fritel, Xavier, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), INSERM CIC 0802 (INSERM - CHU de Poitiers), and Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Postpartum depression, medicine.medical_specialty, MESH: postnatal depression, antidepressant consumption, postpartum care, urinary incontinence, cohort study, Adolescent, 030232 urology & nephrology, Urinary incontinence, Comorbidity, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Cohort Studies, Depression, Postpartum, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, Risk Factors, Prevalence, medicine, Humans, Prospective Studies, Gynecology, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, Incidence, Incidence (epidemiology), Obstetrics and Gynecology, medicine.disease, Antidepressive Agents, [SDV.MHEP.GEO] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Urinary Incontinence, Reproductive Medicine, Cohort, Antidepressant, Female, medicine.symptom, business, Postpartum period, Cohort study
Abstract: International audience; Objective: Our objective was to clarify whether de novo urinary incontinence (UI) in the postpartum period is associated with depressive symptoms or antidepressant drug consumption.Study Design: 2002 pregnant women were recruited between 2003 and 2006 for the EDEN mother–child cohort. This analysis included 1413 women who reported no UI before pregnancy. Severity of UI was assessed by the Sandvik index. At 4 and 12 months postpartum, depressive symptoms were assessed by the Edinburgh Postpartum Depression Scale (EPDS ≥ 10 defines depressive symptoms) and consumption of antidepressant drugs was reported. Results: At 4 months postpartum, 198 women (14%) reported de novo UI; 74% (n=146) reported mild UI, 26% (n=52) moderate, and none severe; prevalence of depressive symptoms was higher in women with than without UI (22.1% vs. 15.9%, p=0.045), and consumption of antidepressant drugs was more frequent (4.7% vs. 1.4%, p=0.005). At 12 months postpartum, the mean (±SD) EPDS score differed between women with than without UI (7.30 ±3.46 vs. 6.57 ±3.72, p=0.016) but was half that at 4 months postpartum. The incidence of new cases of depressive symptoms or antidepressant consumption at 12 months was greater with than without UI (23.8% vs. 15.3%, p=0.012). Conclusions: Although UI is mild in most cases at 4 months postpartum, it is followed by more new cases of depressive symptoms or antidepressant consumption at 12 months.
Published: 2016
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15. Gender-specific factors associated with shorter sleep duration at age 3 years

Author: Marie Aline Charles, Jonathan Bernard, Sabine Plancoulaine, Jérémie Botton, Regis HANKARD, Blandine De Lauzon-Guillain, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Sandrine Lioret, Johanna Lepeule, Barbara Heude, Alice Germa, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), UFR Odontologie [UPD7], Université Paris Diderot - Paris 7 (UPD7), Université Paris Diderot - Paris 7 - UFR Odontologie (UPD7 Odontologie), and Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)
Subjects: Male, Parents, Pediatrics, medicine.medical_specialty, Time Factors, Cognitive Neuroscience, Birth weight, education, Breastfeeding, dietary patterns, Child Behavior, body mass index, Logistic regression, Cohort Studies, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, gender effect, Pre-schooler, Risk Factors, 030225 pediatrics, Surveys and Questionnaires, medicine, Humans, Toddler, health care economics and organizations, 2. Zero hunger, Sex Characteristics, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, General Medicine, medicine.disease, Obesity, Diet, Child, Preschool, Cohort, Sleep Deprivation, sleep duration, Female, Television, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, France, Self Report, Parity (mathematics), Psychology, Sleep, Body mass index, 030217 neurology & neurosurgery, Demography
Abstract: Total sleep duration has been decreasing among children in the last decades. Short sleep duration (SSD) has been associated with deleterious health consequences, such as excess weight/obesity. Risk factors for SSD have already been studied among school-aged children and adolescents, but inconsistent results have been reported regarding possible gender differences. Studies reporting such relationships are scarce in preschoolers, despite the importance of this period for adopting healthy behaviour. We aimed to investigate factors associated with SSD in 3-year-old boys (n = 546) and girls (n = 482) in a French Mother-Child Cohort (EDEN Study). Children were born between 2003 and 2006 in two French university hospitals. Clinical examinations and parent self-reported questionnaires allowed us to collect sociodemographic (e.g. income, education, family situation, child-minding system), maternal [e.g. body mass index (BMI), parity, depression, breastfeeding duration] and child's characteristics (e.g. gender, birth weight, term, physical activity and TV viewing duration, food consumption, usual sleep time). Sleep duration/24-h period was calculated and SSD was defined as
Published: 2015
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16. Relationship between early language skills and the development of inattention/hyperactivity symptoms during the preschool period: Results of the EDEN mother-child cohort

Author: Jonathan Bernard, Franck Ramus, Hugo Peyre, Regis HANKARD, Blandine De Lauzon-Guillain, CEDRIC GALERA, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Johanna Lepeule, Barbara Heude, Judith Van der Waerden, Service Psychiatrie de l'Enfant et de l'Adolescent, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Robert Debré, Laboratoire de sciences cognitives et psycholinguistique (LSCP), Département d'Etudes Cognitives - ENS Paris (DEC), École normale supérieure - Paris (ENS Paris)-École normale supérieure - Paris (ENS Paris)-Centre National de la Recherche Scientifique (CNRS)-École des hautes études en sciences sociales (EHESS), Epidemiologie-Biostatistique [Bordeaux], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux Ségalen [Bordeaux 2], Psychiatrie de l'enfant et de l'adolescent [CH C. Perrens, Bordeaux], SECOP - centre hospitalier Charles Perrens, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Psychiatrie, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Descartes - Paris 5 (UPD5)-PRES Sorbonne Paris Cité-Hôpital Corentin Celton [Issy-les-Moulineaux], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Institut de psychiatrie et neurosciences (U894 / UMS 1266), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Equipe 6 : ORCHAD - Origines précoces de la santé du développement de l'enfant (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), ANR-10-IDEX-0001-02/10-LABX-0087,IEC,Institute of Cognitive Studies of Ecole normale superieure(2010), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Robert Debré, École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École des hautes études en sciences sociales (EHESS)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-PRES Sorbonne Paris Cité-Hôpital Corentin Celton [Issy-les-Moulineaux], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre de Psychiatrie et Neurosciences (U894), ANR-10-IDEX-0001,PSL,Paris Sciences et Lettres(2010), BMC, BMC, Initiative d'excellence - Paris Sciences et Lettres - - PSL2010 - ANR-10-IDEX-0001 - IDEX - VALID, École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS Paris), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Robert Debré, Laboratoire de sciences cognitives et psycholinguistique ( LSCP ), Département d'Etudes Cognitives - ENS Paris ( DEC ), École normale supérieure - Paris ( ENS Paris ) -École normale supérieure - Paris ( ENS Paris ) -École des hautes études en sciences sociales ( EHESS ) -Centre National de la Recherche Scientifique ( CNRS ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Bordeaux Ségalen [Bordeaux 2], Institut Pierre Louis d'Epidémiologie et de Santé Publique ( iPLESP ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ), Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Descartes - Paris 5 ( UPD5 ) -PRES Sorbonne Paris Cité-Hôpitaux Universitaires Paris Ouest - Hôpital Corentin Celton [Issy-les-Moulineaux], Centre de Psychiatrie et Neurosciences ( CPN - U894 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Equipe 6 : ORCHAD - Origines précoces de la santé du développement de l'enfant ( CRESS - U1153 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), and ANR-10-IDEX-0001-02/10-LABX-0087,IEC,Institute of Cognitive Studies of Ecole normale superieure ( 2010 )
Subjects: Male, [SDV]Life Sciences [q-bio], education, Child Behavior, Hyperkinesis, Language Development, Structural equation modeling, Developmental psychology, 03 medical and health sciences, 0302 clinical medicine, Humans, ADHD, 0501 psychology and cognitive sciences, Child, Preschool, Early language, Language, Schools, [ SDV ] Life Sciences [q-bio], 4. Education, 05 social sciences, Mother-Child Relations, [SDV] Life Sciences [q-bio], Psychiatry and Mental health, Language development, Attention Deficit Disorder with Hyperactivity, Child, Preschool, Cohort, Female, Psychology, 030217 neurology & neurosurgery, Period (music), Research Article, 050104 developmental & child psychology
Abstract: Background This study aims to examine bidirectional relationships between children’s language skills and Inattention/Hyperactivity (IH) symptoms during preschool. Method Children (N = 1459) from the EDEN mother-child cohort were assessed at ages 3 and 5.5 years. Language skills were evaluated using the WPPSI-III, NEPSY and ELOLA batteries. Children’s behavior, including IH symptoms, was assessed using the parent-rated Strengths & Difficulties Questionnaire (SDQ). Using a Structural Equation Modeling (SEM) approach, we examined the relationship between language skills and IH symptoms, as well as potential mediating processes. Results SEM analyses indicated a small negative effect of language skills at 3 years on ADHD symptoms at 5.5 years after adjusting for IH symptoms at 3 years (β =−0.12, SE = 0.04, p-value = 0.002). Interpersonal difficulties did not mediate the relationship between early language skills and later IH symptoms, nor was this association reduced after adjusting for a broad range of pre- and postnatal environmental factors and performance IQ. Among different language skills, receptive syntax at 3 years was most strongly related to IH symptoms at 5.5 years. Conclusions Poor language skills at age 3 may predict IH symptoms when a child enters primary school. Implications for the understanding and the prevention of the co-occurrence of language disorders and ADHD are discussed. Electronic supplementary material The online version of this article (doi:10.1186/s12888-016-1091-3) contains supplementary material, which is available to authorized users.
Published: 2015
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17. Multidimensionality of the relationship between social status and dietary patterns in early childhood: longitudinal results from the French EDEN mother-child cohort

Author: Marie Aline Charles, Jonathan Bernard, Sabine Plancoulaine, Jérémie Botton, Regis HANKARD, Blandine De Lauzon-Guillain, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Sandrine Lioret, Johanna Lepeule, Barbara Heude, Alice Germa, Patricia Dargent-Molina, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Ecologie Systématique et Evolution ( ESE ), Université Paris-Sud - Paris 11 ( UP11 ) -AgroParisTech-Centre National de la Recherche Scientifique ( CNRS ), Support for the EDEN mother-child cohort (Étude des Déterminants pré- etpostnatals précoces du développement et de la santé de l’ENfant) was providedby the following organizations: Fondation pour la Recherche Médicale, FrenchMinistry of Research Institut Fédératif de Recherche and Cohort Program,INSERM Nutrition Research Program, French Ministry of Health PerinatalProgram, French Agency for Environment Security (AFFSET), French NationalInstitute for Population Health Surveillance (INVS), Paris-Sud University, FrenchNational Institute for Health Education (INPES), Nestlé, Mutuelle Générale del’Éducation Nationale, French Speaking Association for the Study of Diabetesand Metabolism (Alfediam), National Agency for Research (ANR nonthematicprogram), and National Institute for Research in Public Health (IRESP TGIRCohorte Santé 2008 Program). The study sponsors were not involved in thestudy design, data collection, or data analyses. The present study was supportedby the National Agency for Research (ANR Social determinants of health pro-gram) under the grant agreement n°ANR-12-DSSA-0001 (SOFI project)., EDEN mother-child cohort study group, ANR-12-DSSA-0001,SOFI,Déterminants socio-culturel des pratiques alimentaires dans l'enfance ( 2012 ), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Ecologie Systématique et Evolution (ESE), Université Paris-Sud - Paris 11 (UP11)-AgroParisTech-Centre National de la Recherche Scientifique (CNRS), ANR-12-DSSA-0001,SOFI,Déterminants socio-culturel des pratiques alimentaires dans l'enfance(2012), BMC, BMC, and Déterminants sociaux de santé - Déterminants socio-culturel des pratiques alimentaires dans l'enfance - - SOFI2012 - ANR-12-DSSA-0001 - DSS - VALID
Subjects: Adult, Male, Parents, Gerontology, Adolescent, [SDV]Life Sciences [q-bio], Mothers, Medicine (miscellaneous), Physical Therapy, Sports Therapy and Rehabilitation, Social class, Cohort Studies, Young Adult, Pregnancy, Humans, Medicine, Social inequality, Early childhood, Child Care, Young adult, Dietary patterns, 2. Zero hunger, Toddlers, Nutrition and Dietetics, [ SDV ] Life Sciences [q-bio], business.industry, Research, Preschool children, Feeding Behavior, Middle Aged, Socio-economic position, Mother-Child Relations, Diet, [SDV] Life Sciences [q-bio], Social Class, Socioeconomic Factors, Child, Preschool, Cohort, Fast Foods, Household income, Female, France, business, Social status, Cohort study, Demography, Social inequalities
Abstract: International audience; AbstractBackgroundThe association between socioeconomic position and diet in early childhood has mainly been addressed based on maternal education and household income. We aimed to assess the influence of a variety of social factors from different socio-ecological levels (parents, household and child-care) on multi-time point dietary patterns identified from 2 to 5 y.MethodThis study included 974 children from the French EDEN mother-child cohort. Two multi-time point dietary patterns were derived in a previous study: they correspond to consistent exposures to either core- or non-core foods across 2, 3 and 5 y and were labelled “Guidelines” and “Processed, fast-foods”. The associations of various social factors collected during pregnancy (age, education level) or at 2-y follow-up (mother’s single status, occupation, work commitments, household financial disadvantage, presence of older siblings and child-care arrangements) with each of the two dietary patterns, were assessed by multivariable linear regression analysis.ResultsThe adherence to a diet close to “Guidelines” was positively and independently associated with both maternal and paternal education levels. The adherence to a diet consistently composed of processed and fast-foods was essentially linked with maternal variables (younger age and lower education level), household financial disadvantage, the presence of older sibling (s) and being cared for at home by someone other than the mother.ConclusionsMultiple social factors operating at different levels (parents, household, and child-care) were found to be associated with the diet of young children. Different independent predictors were found for each of the two longitudinal dietary patterns, suggesting distinct pathways of influence. Our findings further suggest that interventions promoting healthier dietary choices for young children should involve both parents and take into account not only household financial disadvantage but also maternal age, family size and options for child-care.
Published: 2015
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18. Impact on obstetric outcome of third-trimester screening for small-for-gestational-age fetuses

Author: Marie Aline Charles, Regis HANKARD, Blandine De Lauzon-Guillain, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Johanna Lepeule, Barbara Heude, Alice Germa, Service d'Obstétrique et de Gynécologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Imagerie Adaptative Diagnostique et Interventionnelle (IADI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Laboratoire de catalyse en chimie organique (LACCO), Université de Poitiers-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Université Paris-Sud - Paris 11 (UP11), UL, IADI, and Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Pediatrics, medicine.medical_specialty, Pregnancy Trimester, Third, Population, Ultrasonography, Prenatal, Cohort Studies, Predictive Value of Tests, Pregnancy, Positive predicative value, medicine, Humans, Radiology, Nuclear Medicine and imaging, Prospective Studies, small-for-gestational age, education, Prospective cohort study, reproductive and urinary physiology, third trimester, education.field_of_study, Fetus, Fetal Growth Retardation, Labor, Obstetric, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Radiological and Ultrasound Technology, Cesarean Section, business.industry, ultrasound, screening, Ultrasound, Infant, Newborn, Pregnancy Outcome, Obstetrics and Gynecology, General Medicine, medicine.disease, female genital diseases and pregnancy complications, 3. Good health, Fetal Weight, Reproductive Medicine, Infant, Small for Gestational Age, Gestation, Small for gestational age, Female, business, Neonatal resuscitation, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; OBJECTIVES:To evaluate the performance of screening for small-for-gestational-age (SGA) fetuses by ultrasound biometry at 30-35 weeks' gestation, and to determine the impact of screening on obstetric and neonatal outcomes.METHODS:For this prospective cohort study, pregnant women were recruited from two French university maternity centers between 2003 and 2006. Performance measures of third-trimester biometry for the prediction of SGA, defined as estimated fetal weight
Published: 2015
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19. Maternal tobacco smoking in pregnancy and children's socio-emotional development at age 5: the EDEN mother-child birth cohort study

Author: Marie Aline Charles, Regis HANKARD, Blandine De Lauzon-Guillain, CEDRIC GALERA, Aude Bardot, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Johanna Lepeule, Barbara Heude, Alice Germa, Judith Van der Waerden, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants (UMR_S 953), Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de psychiatrie infantile et adolescente, Centre Hospitalier Charles PERRENS, Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique ( iPLESP ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants ( UMR_S 953 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris-Sud - Paris 11 ( UP11 ), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), and Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale ( INSERM )
Subjects: Adult, Male, medicine.medical_specialty, Offspring, Breastfeeding, Addiction, Family income, ADHD symptoms, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Pregnancy, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Child, Maternal Behavior, Psychiatry, Cigarette, Maternal-Fetal Exchange, Depression, business.industry, Smoking, Infant, Newborn, Strengths and Difficulties Questionnaire, medicine.disease, Mother-Child Relations, 030227 psychiatry, Psychiatry and Mental health, Low birth weight, Attention Deficit Disorder with Hyperactivity, Premature birth, Child, Preschool, Female, Mental health, France, medicine.symptom, business, Cohort study, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Demography
Abstract: BackgroundThere is debate as to whether maternal tobacco use in pregnancy is related to offspring behaviour later on. We tested this association examining multiple aspects of children's behaviour at age 5 and accounting for parental smoking outside of pregnancy, as well as child and family characteristics.MethodsData come from a prospective community based birth cohort study (EDEN; n = 1113 families in France followed since pregnancy in 2003–2005 until the child's 5th birthday). Maternal tobacco use in pregnancy was self-reported. Children's socio-emotional development (emotional symptoms, conduct problems, symptoms of hyperactivity/inattention, peer relationship problems, prosocial behaviour) was assessed by mothers using the Strengths and Difficulties Questionnaire (SDQ) at age 5 years. Logistic regression analyses controlled for Inverse Probability Weights (IPW) of maternal tobacco use calculated based on study center, children's characteristics (sex, premature birth, low birth weight, breastfeeding), maternal characteristics (age at the child's birth, psychological difficulties and alcohol use in pregnancy, post-pregnancy depression, and smoking), paternal smoking in and post-pregnancy, parental educational attainment, family income, parental separation, and maternal negative life events.ResultsMaternal smoking in pregnancy only predicted children's high symptoms of hyperactivity/inattention (sex and study center-adjusted ORs: maternal smoking in the 1st trimester: 1.95, 95%CI: 1.13–3.38; maternal smoking throughout pregnancy: OR = 2.11, 95%CI: 1.36–3.27). In IPW-controlled regression models, only children of mothers who smoked throughout pregnancy had significantly elevated levels of hyperactivity/inattention (OR = 2.20, 95%CI: 1.21–4.00).ConclusionsMaternal tobacco smoking in pregnancy may contribute directly or through epigenetic mechanisms to children's symptoms of hyperactivity/inattention.
Published: 2015
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20. Comparison of two data collection processes in clinical studies: electronic and paper case report forms

Author: Éric Konofal, Anaïs Le Jeannic, Regis HANKARD, Tabassome SIMON, Raphaël Serreau, Dominique BREMOND-GIGNAC, Département de la recherche clinique et du développement, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Unité de Recherche Clinique en Economie de la santé d'Ile de France (URC Eco), Unité d'Épidémiologie clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 (UPD7)-PRES Sorbonne Paris Cité, Service de Santé Publique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier, on behalf of the CompaRec Investigators, and BMC, Ed.
Subjects: Adult, Male, medicine.medical_specialty, Databases, Factual, 020205 medical informatics, Epidemiology, Cost-Benefit Analysis, Health Personnel, MEDLINE, Health Informatics, 02 engineering and technology, Logistic regression, Electronic data collection, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, Statistics, 0202 electrical engineering, electronic engineering, information engineering, Electronic Health Records, Humans, Medicine, Medical physics, Time management, 030212 general & internal medicine, Duration (project management), Work satisfaction, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Data collection, Cost–benefit analysis, business.industry, Data Collection, Time Management, Costs, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Data quality, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Job satisfaction, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Research Article
Abstract: Background Electronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs). Previous studies suggested that eCRFs avoided mistakes, shortened the duration of clinical studies and reduced data collection costs. Methods Our objectives were to describe and contrast both objective and subjective efficiency of pCRF and eCRF use in clinical studies. A total of 27 studies (11 eCRF, 16 pCRF) sponsored by the Paris hospital consortium, conducted and completed between 2001 and 2011 were included. Questionnaires were emailed to investigators of those studies, as well as clinical research associates and data managers working in Paris hospitals, soliciting their level of satisfaction and preferences for eCRFs and pCRFs. Mean costs and timeframes were compared using bootstrap methods, linear and logistic regression. Results The total cost per patient was 374€ ±351 with eCRFs vs. 1,135€ ±1,234 with pCRFs. Time between the opening of the first center and the database lock was 31.7 months Q1 = 24.6; Q3 = 42.8 using eCRFs, vs. 39.8 months Q1 = 31.7; Q3 = 52.2 with pCRFs (p = 0.11). Electronic CRFs were globally preferred by all (31/72 vs. 15/72 for paper) for easier monitoring and improved data quality. Conclusions This study found that eCRFs and pCRFs are used in studies with different patient numbers, center numbers and risk. The first ones are more advantageous in large, low–risk studies and gain support from a majority of stakeholders.
Published: 2014
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21. Pseudohypoparathyroidism Type Ia: A Regional Clinical and Biological Study of Eleven Cases

Author: Simon Kayemba-Kay's, Cedric Tripon, Catherine Boniface, Sophie Troller, Ariane Zelinsky, and Regis Hankard
Published: 2011
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22. Maternal Depression Trajectories and Children's Behavior at Age 5 Years

Author: Marie Aline Charles, Jonathan Bernard, Regis HANKARD, Blandine De Lauzon-Guillain, CEDRIC GALERA, Xavier FRITEL, Marie-Josephe Saurel-Cubizolles, Johanna Lepeule, Barbara Heude, Alice Germa, and Judith Van der Waerden
Subjects: Adult, Male, Pediatrics, medicine.medical_specialty, Time Factors, Mothers, Child Behavior Disorders, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, Epidemiology, Humans, Medicine, 0501 psychology and cognitive sciences, Early childhood, Psychiatry, Depression (differential diagnoses), Pregnancy, Depression, business.industry, 05 social sciences, Strengths and Difficulties Questionnaire, medicine.disease, 3. Good health, 030227 psychiatry, Child, Preschool, Edinburgh Postnatal Depression Scale, Pediatrics, Perinatology and Child Health, Population study, Female, business, 050104 developmental & child psychology, Cohort study
Abstract: To assess the relationship between trajectories of maternal depression from pregnancy to the child's age of 5 years and children's emotional and behavioral difficulties at age 5 years.Mother-child pairs (n = 1183) from the EDEN mother-child birth cohort study based in France were followed from 24 to 28 weeks of pregnancy to the child's fifth birthday. Children's behavior at age 5 years was assessed with the Strengths and Difficulties Questionnaire. Maternal depression was assessed repeatedly with the Center for Epidemiological Studies Depression questionnaire (pregnancy, 3, and 5 years of age) and the Edinburgh Postnatal Depression Scale (4, 8, and 12 months postpartum). Homogeneous latent trajectory groups of maternal depression were identified within the study population and correlated with Strengths and Difficulties Questionnaire scores by the use of multivariate linear regression analyzes.Five trajectories of maternal symptoms of depression were identified: no symptoms (62.0%); persistent intermediate-level depressive symptoms (25.3%); persistent high depressive symptoms (4.6%); high symptoms in pregnancy only (3.6%); and high symptoms in the child's preschool period only (4.6%). Children whose mothers had persistent depressive symptoms--either intermediate or high--had the greatest levels of emotional and behavioral difficulties at age 5 years. In addition, compared with children whose mothers were never depressed, those whose mothers had high symptoms in the preschool period also had increased levels of emotional symptoms, conduct problems, and peer problems.Maternal depression symptoms are related to children's emotional and behavioral problems, particularly if they are persistent (29.9%) or occur during early childhood (4.6%).
Published: 2015
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23. Collaborateurs

Author: Benoist, Grégoire, Bourrillon, Antoine, Delacourt, Christophe, Audry, Georges, Lechevallier, Joël, Tounian, Patrick, Jean-Baptiste, Arnoux, Frédéric, Auber, Stéphane, Auvin, Grégoire, Benoist, Etienne, Bidat, Arnaud, Bonnard, Damien, Bonnet, Antoine, Bourrillon, Dominique, Brémond-Gignac, Jean-Claude, Carel, Brigitte, Chabrol, Yves, Chaix, Hervé, Chambost, Alain, Chantepie, Gérard, Chéron, Bertrand, Chevallier, Régis, Coutant, Jean-Christophe, Cuvellier, Jean-Hugues, Dalle, Stéphane, Dauger, Christophe, Delacourt, François, Doz, Georges, Deschênes, Eric, Dobremez, Brigitte, Fauroux, Albert, Faye, Pierre, Foucaud, Elisabeth, Fournier-Charrière, Martine, François, Jean, Gaschignard, Maxime, Gérard, Frédéric, Gottrand, Christèle, Gras-Leguen, Claire, Grimwood, Emmanuel, Grimprel, Régis, Hankard, Sébastien, Hascoet, (de) Elsa, Kermorvant, André, Labbé, Philippe, Labrune, Isabelle, Lacreuze, (de) Yvan, La Monneraye, Joël, Lechevallier, Alain, Lefèvre-Utile, Juliane, Léger, Anne, Lienhardt, (de) Pascale, Lonlay, Mathie, Lorrot, Natalie, Loundon, Jean-Christophe, Mercier, Thierry, Merrot, Matthieu, Milh, Pierre, Mouriquand, Olivier, Mouterde, Pierre-Yves, Mure, Sylvie, Odent, Laurent, Pasquier, Capucine, Picard, Guillaume, Podevin, Philippe, Ravasse, Rachel, Raynaud, Jérémie, Rosain, Michel, Roussey, Frank, Ruemmele, Philippe, Sachs, Jacques, Sarles, Frédérique, Sauvat, Gudrun, Schleiermacher, Isabelle, Sermet-Gaudelus, Chantal, Stheneur, Patrick, Tounian, (de) Renaud, Tournemire, Barbara, Tourniaire, Patrick, Truffert, Dominique, Turk, François, Varlet, Alain, Verloes, and Chantal, Wood
Published: 2017
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24. Do Emotion Dysregulation, Alexithymia and Personality Dimensions Explain the Association Between Attention-Deficit/Hyperactivity Disorder and Binge Eating Among Bariatric Surgery Candidates?

Author: Sarah El Archi, Paul Brunault, Arnaud De Luca, Samuele Cortese, Régis Hankard, Céline Bourbao-Tournois, Nicolas Ballon, Christian Réveillère, and Servane Barrault
Subjects: addictive-like eating, binge eating disorder, ADHD, impulsivity, personality dimensions, emotion dysregulation, Psychology, BF1-990
Abstract: Background: Addictive-like eating and attention-deficit/hyperactivity disorder (ADHD) are both common among persons seeking treatment for severe obesity. Given that ADHD and addictive-like eating, especially binge eating (BE) and food addiction (FA), are both strongly associated with personality dimensions and emotion dysregulation, it is possible emotional and personality characteristics contribute to the link between addictive-like eating behaviors and ADHD in people with severe obesity. This study aimed to investigate the psychological factors associated with BE and FA in bariatric surgery candidates, and to explore the mediational role of emotional factors (emotion dysregulation and alexithymia) and personality dimensions in the association between ADHD and BE.Method: Two hundred and eighty-two (n = 282) bariatric surgery candidates were recruited during the systematic preoperative psychiatric assessment (University Hospital of Tours, France). We assessed significant BE (Binge Eating Scale), probable adult ADHD (Wender Utah Render Scale and Adult ADHD Self-Report Scale), FA (Yale Food Addiction Scale 2.0, YFAS 2.0), emotion dysregulation (Difficulties in Emotion Regulation Scale-16), alexithymia (Toronto Alexithymia Scale-20) and personality dimensions (Big Five Inventory). Mediation analyses were performed using the PROCESS macro for IBM SPSS Statistics 22.Results: Prevalence of probable adult ADHD, significant BE and FA were 8.2, 19.1, and 26.6%, respectively. Participants who screened positive for addictive-like eating showed higher prevalence of probable adult ADHD, as well as higher scores on adult and childhood ADHD symptoms. They also reported lower conscientiousness, but higher emotion dysregulation, higher alexithymia, and higher neuroticism. Only BE (as opposed to FA) was also associated with lower scores on agreeableness and openness. Analysis of the association between adult ADHD and BE suggests that emotion dysregulation, conscientiousness, agreeableness, and neuroticism are total mediators and alexithymia a partial mediator.Conclusion: Our findings suggest a significant association between ADHD and addictive-like eating among bariatric surgery candidates, and also suggest a significant role of emotion dysregulation and personality dimensions in this association. For individuals with ADHD and obesity, eating may be a way to cope with negative emotions, potentially increasing the risk for addictive-like eating behavior.
Published: 2021
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25. Proteomic pattern of breast milk discriminates obese mothers with infants of delayed weight gain from normal‐weight mothers with infants of normal weight gain

Author: Christo Atanassov, Etienne Viallemonteil, Charlotte Lucas, Marylise Perivier, Stéphane Claverol, Roland Raimond, and Régis Hankard
Subjects: breast milk, infant weight gain, maternal obesity, pIgR, SELDI biomarker, Biology (General), QH301-705.5
Abstract: We previously reported that exclusively breastfed infants born to mothers with pregestational obesity gain less weight during the first month after birth than those born to mothers of normal pregestational weight. This issue is potentially important since lower weight gain in breastfed infants of obese mothers might increase the risk of developing later obesity. Breast milk quality and quantity, together with breastfeeding practice, possibly influence infants’ feeding behavior, appetite control, and regulation of growth later in life. The issue of whether breast milk protein patterns from obese mothers differ in composition from those of non‐obese mothers remains largely unexplored. Here, we established a breast milk proteomic pattern that discriminates obese mothers and infants with delayed weight gain at 1 month after birth from normal‐weight mothers with infants of the same age and with normal weight gain. Obese mothers were matched to normal‐weight mothers (n = 26; body mass index 33.5 ± 3.2 vs 21.5 ± 1.5 kg·m−2). The mean weight gain of infants in the obese group at 1 month after birth was 430.8 g lower than that of the infants in the control group. Analysis of the breast milk delipidized fraction by surface‐enhanced laser desorption/ionization on CM10 and Q10 arrays was followed by MS‐assisted purification and LC‐MS/MS microsequencing of a selected biomarker. We identified 15 candidate protein biomarkers, seven of which were overexpressed in the obese group and eight in the normal‐weight group. One of the most significant candidate biomarkers, overexpressed in the obese group, was identified as a fragment of the sixth extracellular domain of the polymeric immunoglobulin receptor. Further structural identification of these candidate biomarkers and their validation in clinical assays may facilitate the development of a predictive immunoassay.
Published: 2019
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26. N-3 Fatty Acid Supplementation Impacts Protein Metabolism Faster Than it Lowers Proinflammatory Cytokines in Advanced Breast Cancer Patients: Natural 15N/14N Variations during a Clinical Trial

Author: Olivier L. Mantha, Régis Hankard, Illa Tea, Anne-Marie Schiphorst, Jean-François Dumas, Virginie Berger, Caroline Goupille, Philippe Bougnoux, and Arnaud De Luca
Subjects: nitrogen-15 isotopic abundance, carbon-13 isotopic abundance, n-3 fatty acids, EPA, DHA, protein and amino acid metabolism, Microbiology, QR1-502
Abstract: While clinical evidence remains limited, an extensive amount of research suggests a beneficial role of n-3 polyunsaturated fatty acid supplementation in cancer treatment. One potential benefit is an improvement of protein homeostasis, but how protein metabolism depends on proinflammatory cytokines in this context remains unclear. Here, using the natural abundance of the stable isotopes of nitrogen as a marker of changes in protein metabolism during a randomized, double-blind, controlled clinical trial, we show that protein homeostasis is affected way faster than proinflammatory cytokines in metastatic breast cancer patients supplemented with n-3 polyunsaturated fatty acids. We provide some evidence that this response is unrelated to major changes in whole-body substrate oxidation. In addition, we demonstrate that more fatty acids were impacted by metabolic regulations than by differences in their intake levels during the supplementation. This study documents that the percentage of patients that complied with the supplementation decreased with time, making compliance assessment crucial for the kinetic analysis of the metabolic and inflammatory responses. Our results highlight the time-dependent nature of metabolic and inflammatory changes during long-chain n-3 fatty acid supplementation.
Published: 2022
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27. The Modified Yale Food Addiction Scale 2.0: Validation Among Non-Clinical and Clinical French-Speaking Samples and Comparison With the Full Yale Food Addiction Scale 2.0

Author: Paul Brunault, Sylvie Berthoz, Ashley N. Gearhardt, Fabien Gierski, Arthur Kaladjian, Eric Bertin, André Tchernof, Laurent Biertho, Arnaud de Luca, Régis Hankard, Robert Courtois, Nicolas Ballon, Farid Benzerouk, and Catherine Bégin
Subjects: food addiction, substance-related and addictive disorders, obesity surgery, eating addiction, eating disorders, psychometrics, Psychiatry, RC435-571
Abstract: ObjectivesThe modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) was designed to assess food addiction using a shorter version than the YFAS 2.0. We lack data about the psychometric properties of the mYFAS 2.0 in patients with obesity, as well as studies comparing the psychometric properties of the mYFAS 2.0 versus the full YFAS 2.0. This study aimed to validate the French-language mYFAS 2.0 in a non-clinical population (study 1, n = 250), to determine the yet unknown psychometric properties of this scale in patients with obesity (study 2, n = 345), and to compare the full YFAS 2.0 and the mYFAS 2.0 in terms of food addiction (FA) prevalence and symptoms detection in both populations.MethodStudy 1 included 250 non-clinical individuals (non-underweight and non-obese persons screened negative for eating disorders). Study 2 included 345 bariatric surgery candidates recruited in three centers (Québec, Canada; Reims and Tours, France). The mYFAS 2.0 structure was investigated using confirmatory factorial analyses with tetrachoric correlations. Convergent validity was tested using the full YFAS 2.0, the Binge Eating Scale (both studies), the revised 18-item Three Factor Eating Questionnaire (study 1), the Beck Depression Inventory (study 2), and the body mass index (BMI; both studies).ResultsThe mYFAS 2.0 was unidimensional, and had adequate (study 1: KR-20 = .78) and acceptable (study 2: KR-20 = .73) internal consistency. In study 1, the mYFAS 2.0 had good convergent validity with the YFAS 2.0, BMI, binge eating, cognitive restraint, uncontrolled eating and emotional eating; in study 2, the mYFAS 2.0 had good convergent validity with the YFAS 2.0, binge eating, depression, but not BMI. Participants endorsed fewer symptoms with the mYFAS 2.0 than with the YFAS 2.0; FA prevalences were similar between questionnaires in the non-clinical, but not in the clinical sample. A FA ‘diagnosis’ and risk of binge eating disorder were associated but did not completely overlap.ConclusionsThe mYFAS 2.0 has close psychometric properties to the YFAS 2.0 in non-clinical and clinical samples. However, the use of the mYFAS 2.0 in bariatric surgery candidates might lead to a significant underestimation of FA prevalence and number of FA symptoms.
Published: 2020
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28. Contribution des laits de croissance et des compléments à l’adéquation nutritionnelle de régimes alimentaires d’enfants en bas âge. [Role of Young Child Formulae and Supplements to Ensure Nutritional Adequacy in Young Children [1]

Author: Chloé M.C. BROUZES, Florent VIEUX, Matthieu MAILLOT, André BRIEND, Régis HANKARD, Anne LLUCH, and Nicole DARMON
Subjects: Lait de croissance, Enfants en bas âge, Compléments, Modélisation de régimes alimentaires individuels, Alimentation, Nutrition. Foods and food supply, TX341-641, Medicine (General), R5-920
Abstract: Introduction. L’autorité européenne de sécurité des aliments (AESA) assure que les laits de croissance « n’apportent pas de valeur supplémentaire à une alimentation équilibrée pour répondre aux besoins nutritionnels des enfants en bas âge ». Objectifs. Cette étude quantifie les modifications alimentaires minimales nécessaires pour atteindre l’adéquation nutritionnelle chez des enfants en bas âge selon leur consommation ou non de laits de croissance et/ou de compléments. Méthodologie. L’application de modèles de programmation linéaire aux données de l’enquête alimentaire nationale au Royaume Uni sur les consommations alimentaires de 1147 enfants de 12-18 mois a permis d’identifier les modifications alimentaires minimales nécessaires, d’abord en changeant uniquement les quantités des aliments déjà consommés par chaque enfant (répertoire alimentaire), puis en autorisant l’introduction de nouveaux aliments. Résultats. Le groupe d’enfants ne consommant ni laits de croissance ni compléments était majoritaire (61,6 %). Pour seulement 1% de ces enfants, il était possible d’atteindre l’adéquation nutritionnelle à partir des aliments de leur répertoire alimentaire, contre 74,4% des enfants du groupe consommant des laits de croissance et des compléments. Lorsque l’introduction de nouveaux aliments était autorisée, les changements alimentaires requis étaient moindres lorsque les laits de croissance et les compléments faisaient initialement partie du répertoire de l’enfant. Dans l’échantillon total, les principales modifications alimentaires requises étaient une augmentation du lait de croissance et une diminution du lait de vache (respectivement +226 et −181 g/jour). Conclusions. Augmenter la consommation de lait de croissance et/ou des compléments constitue la voie la plus simple de couverture des recommandations nutritionnelles de l’AESA.
Published: 2017

29. Stable Isotope Abundance and Fractionation in Human Diseases

Author: Illa Tea, Arnaud De Luca, Anne-Marie Schiphorst, Mathilde Grand, Sophie Barillé-Nion, Eric Mirallié, Delphine Drui, Michel Krempf, Régis Hankard, and Guillaume Tcherkez
Subjects: isotope effect, fractionation, metabolic partitioning, diabetes, cancer, metal homeostasis, Microbiology, QR1-502
Abstract: The natural abundance of heavy stable isotopes (13C, 15N, 18O, etc.) is now of considerable importance in many research fields, including human physiology. In fact, it varies between tissues and metabolites due to isotope effects in biological processes, that is, isotope discriminations between heavy and light isotopic forms during enzyme or transporter activity. The metabolic deregulation associated with many diseases leads to alterations in metabolic fluxes, resulting in changes in isotope abundance that can be identified easily with current isotope ratio technologies. In this review, we summarize the current knowledge on changes in natural isotope composition in samples (including various tissues, hair, plasma, saliva) found in patients compared to controls, caused by human diseases. We discuss the metabolic origin of such isotope fractionations and highlight the potential of using isotopes at natural abundance for medical diagnosis and/or prognostic.
Published: 2021
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30. Protein restricted diet during gestation and/or lactation in mice affects 15N natural isotopic abundance of organs in the offspring: Effect of diet 15N content and growth.

Author: Karine Bernardo, Céline Jousse, Pierre Fafournoux, Anne-Marie Schiphorst, Mathilde Grand, Richard J Robins, Régis Hankard, and Arnaud De Luca
Subjects: Medicine, Science
Abstract: OBJECTIVES AND STUDY:This study aimed at measuring the effect in normal to restricted protein diets with specific 15N natural isotopic abundance (NIA) given during gestation and/or lactation on the 15N NIA of fur, liver and muscle in dams and their offspring from birth to adulthood. The secondary aim was to study the effect of growth on the same parameters. METHODS:Female Balb/c mice were fed normal protein diet containing 22% protein or isocaloric low protein diet containing 10% protein throughout gestation. Dam's diets were either maintained or switched to the other diet until weaning at 30 days. All animals were fed standard chow thereafter. Offspring were sacrificed at 1, 11, 30, 60, 480 days and a group of dams at d1. Growth was modeled as an exponential function on the group followed up until 480 days. Fur, liver and muscle were sampled at sacrifice and analyzed for bulk 15N NIA. Fixed effects and interactions between fixed effects and random elements were tested by three-way ANOVA. RESULTS:Higher 15N NIA in the diet resulted in higher organ 15N NIA. Switching from one diet to another changed 15N NIA in each organ. Although dam and offspring shared the same isotopic environment during gestation, 15N NIA at day 1 was higher in dams. Growth rate did not differ between groups after 10 days and decreased between 1 and 5 months. 15N NIA differed between organs and was affected by growth and gestation/lactation. CONCLUSION:Dietary 15N NIA is a major determinant of the 15N NIA of organs. 15N NIA depended on organ and age (i.e. growth) suggesting an effect of metabolism and/or dilution space. Post-natal normal-protein diet of lactating dams could reverse the effect of a protein-restricted diet during gestation on the offspring growth. Measuring 15N NIA in various matrices may open a field of application particularly useful in studying the pre- and post-natal origins of health and disease.
Published: 2018
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31. Higher Leptin but Not Human Milk Macronutrient Concentration Distinguishes Normal-Weight from Obese Mothers at 1-Month Postpartum.

Author: Arnaud De Luca, Marine Frasquet-Darrieux, Marie-Agnès Gaud, Patricia Christin, Clair-Yves Boquien, Christine Millet, Manon Herviou, Dominique Darmaun, Richard J Robins, Pierre Ingrand, and Régis Hankard
Subjects: Medicine, Science
Abstract: Exclusively breastfed infants born to obese mothers have previously been shown to gain less weight by 1-month postpartum than infants of normal-weight mothers. Our hypothesis is that human milk composition and volume may differ between obese and normal-weight mothers.To compare human milk leptin, macronutrient concentration, and volume in obese and normal-weight mothers. Mother and infant characteristics were studied as secondary aims.This cross-sectional observational study compared 50 obese mothers matched for age, parity, ethnic origin, and educational level with 50 normal-weight mothers. Leptin, macronutrient human milk concentration, and milk volume were determined at 1 month in exclusively breastfed infants. Mother characteristics and infant growth were recorded.Human milk leptin concentration was higher in obese mothers than normal-weight mothers (4.8±2.7 vs. 2.5±1.5 ng.mL-1, p
Published: 2016
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32. Glutamine Supplementation in Sick Children: Is It Beneficial?

Author: Elise Mok and Régis Hankard
Subjects: Nutritional diseases. Deficiency diseases, RC620-627
Abstract: The purpose of this review is to provide a critical appraisal of the literature on Glutamine (Gln) supplementation in various conditions or illnesses that affect children, from neonates to adolescents. First, a general overview of the proposed mechanisms for the beneficial effects of Gln is provided, and subsequently clinical studies are discussed. Despite safety, studies are conflicting, partly due to different effects of enteral and parenteral Gln supplementation. Further insufficient evidence is available on the benefits of Gln supplementation in pediatric patients. This includes premature infants, infants with gastrointestinal disease, children with Crohn's disease, short bowel syndrome, malnutrition/diarrhea, cancer, severe burns/trauma, Duchenne muscular dystrophy, sickle cell anemia, cystic fibrosis, and type 1 diabetes. Moreover, methodological issues have been noted in some studies. Further mechanistic data is needed along with large randomized controlled trials in select populations of sick children, who may eventually benefit from supplemental Gln.
Published: 2011
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33. Lack of functional benefit with glutamine versus placebo in Duchenne muscular dystrophy: a randomized crossover trial.

Author: Elise Mok, Guy Letellier, Jean-Marie Cuisset, André Denjean, Frédéric Gottrand, Corinne Alberti, and Régis Hankard
Subjects: Medicine, Science
Abstract: Oral glutamine decreases whole body protein breakdown in Duchenne muscular dystrophy (DMD). We evaluated the functional benefit of 4 months oral glutamine in DMD.30 ambulant DMD boys were included in this double-blind, randomized crossover trial with 2 intervention periods: glutamine (0.5 g/kg/d) and placebo, 4 months each, separated by a 1-month wash-out, at 3 outpatient clinical investigation centers in France. Functional benefit was tested by comparing glutamine versus placebo on change in walking speed at 4 months. Secondary outcome measures were: 2-minute walk test, work, power, muscle mass (urinary creatinine), markers of myofibrillar protein breakdown (urinary 3-methyl-histidine/creatinine), serum creatine phospho-kinase, body composition (fat free mass, fat mass percentage), safety and oral nutrient intake. There was no improvement in the primary end point (walking speed) or in secondary measures of muscle function (2-minute walk test, work, power) in the glutamine group compared with placebo. However, subjects receiving glutamine or placebo showed no deterioration in functional measures over the course of the 9-month trial. No differences in muscle mass, markers of protein breakdown or serum creatine phosho-kinase were observed, except for a blunted increase in fat free mass in the glutamine group which led to a greater increase in fat mass percentage. Glutamine was safe and well-tolerated.This trial did not identify additional benefit of 4 months oral glutamine over placebo on muscle mass or function in ambulatory DMD boys. Although apparently safe, current data cannot support routine supplementation in this population as a whole, until further research proves otherwise.(ClinicalTrials.gov) NCT00296621.
Published: 2009
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33 results on '"Regis Hankard"'

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