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152 results on '"Lachin, J."'

1. Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes

Author

Haller, Michael J, Schatz, Desmond A, Skyler, Jay S, Krischer, Jeffrey P, Bundy, Brian N, Miller, Jessica L, Atkinson, Mark A, Becker, Dorothy J, Baidal, David, DiMeglio, Linda A, Gitelman, Stephen E, Goland, Robin, Gottlieb, Peter A, Herold, Kevan C, Marks, Jennifer B, Moran, Antoinette, Rodriguez, Henry, Russell, William, Wilson, Darrell M, Greenbaum, Carla J, Greenbaum, C, Atkinson, M, Baidal, D, Battaglia, M, Becker, D, Bingley, P, Bosi, E, Buckner, J, Clements, M, Colman, P, DiMeglio, L, Evans-Molina, C, Gitelman, S, Goland, R, Gottlieb, P, Herold, K, Knip, M, Krischer, J, Lernmark, A, Moore, W, Moran, A, Muir, A, Palmer, J, Peakman, M, Philipson, L, Raskin, P, Redondo, M, Rodriguez, H, Russell, W, Spain, L, Schatz, DA, Sosenko, J, Wherrett, D, Wilson, D, Winter, W, Ziegler, A, Anderson, M, Antinozzi, P, Benoist, C, Blum, J, Bourcier, K, Chase, P, Clare-Salzler, M, Clynes, R, Cowie, C, Eisenbarth, G, Fathman, CG, Grave, G, Harrison, L, Hering, B, Insel, R, Jordan, S, Kaufman, F, Kay, T, Kenyon, N, Klines, R, Lachin, J, Leschek, E, Mahon, J, Marks, JB, Monzavi, R, Nanto-Salonen, K, Nepom, G, Orban, T, Parkman, R, Pescovitz, M, Peyman, J, Pugliese, A, Ridge, J, Roep, B, Roncarolo, M, Savage, P, Simell, O, Sherwin, R, Siegelman, M, Skyler, JS, Steck, A, Thomas, J, Trucco, M, and Wagner, J

Subjects
Pediatric, Diabetes, Clinical Trials and Supportive Activities, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Adolescent, Adult, Antilymphocyte Serum, C-Peptide, Child, Cytoprotection, Diabetes Mellitus, Type 1, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin, Granulocyte Colony-Stimulating Factor, Humans, Insulin-Secreting Cells, Male, Pilot Projects, Polyethylene Glycols, Recombinant Proteins, Young Adult, Type 1 Diabetes TrialNet ATG-GCSF Study Group
Abstract

ObjectiveA pilot study suggested that combination therapy with low-dose anti-thymocyte globulin (ATG) and pegylated granulocyte colony-stimulating factor (GCSF) preserves C-peptide in established type 1 diabetes (T1D) (duration 4 months to 2 years). We hypothesized that 1) low-dose ATG/GCSF or 2) low-dose ATG alone would slow the decline of β-cell function in patients with new-onset T1D (duration

Published
2018

6. Results of the ADOPT trial: 97

Author

Viberti, G C, Kahn, S, Haffner, S, Herman, W, Holman, R, Lachin, J, Zinman, B, Heise, M JN, Kravitz, B, and OʼNeill, C

Published
2006

9. Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes A Randomized Clinical Trial

Author

Greenbaum, C., Atkinson, M., Baidal, D., Battaglia, M., Bingley, P., Bosi, E., Buckner, J., Clements, M., Colman, P., DiMeglio, L., Evans-Molina, C., Gitelman, S., Goland, R., Gottlieb, P., Herold, K., Knip, M., Krischer, J., Lernmark, A., Moore, W., Moran, A., Muir, A., Palmer, J., Peakman, M., Philipson, L., Raskin, P., Redondo, M., Rodriguez, H., Russell, W., Spain, L., Schatz, D.A., Sosenko, J., Wherrett, D., Wilson, D., Winter, W., Ziegler, A., Anderson, M., Antinozzi, P., Benoist, C., Blum, J., Bourcier, K., Chase, P., Clare-Salzler, M., Clynes, R., Cowie, C., Eisenbarth, G., Fathman, C.G., Grave, G., Harrison, L., Hering, B., Insel, R., Jordan, S., Kaufman, F., Kay, T., Kenyon, N., Klines, R., Lachin, J., Leschek, E., Mahon, J., Marks, J.B., Monzavi, R., Nanto-Salonen, K., Nepom, G., Orban, T., Parkman, R., Pescovitz, M., Peyman, J., Pugliese, A., Ridge, J., Roep, B., Roncarolo, M., Savage, P., Simell, O., Sherwin, R., Siegelman, M., Skyler, J.S., Thomas, J., Trucco, M., Wagner, J., Greenbaum, C.J., Krischer, J.P., Rafkin, L., Foulkes, M., Krause-Steinrauf, H., Lachin, J.M., Malozowski, S., Zafonte, S.J., Kenyon, N.S., Santiago, I., Bundy, B., Abbondondolo, M., Adams, T., Asif, D.A.I., Boonstra, M., Boulware, D., Burroughs, C., Cuthbertson, D., Eberhard, C., Fiske, S., Ford, J., Garmeson, J., Guillette, H., Geyer, S., Hays, B., Henderson, C., Henry, M., Heyman, K., Hsiao, B., Karges, C., Kinderman, A., Lane, L., Leinbach, A., Liu, S., Lloyd, J., Malloy, J., Maddox, K., Martin, J., Miller, J., Moore, M., Muller, S., Nguyen, T., O'Donnell, R., Parker, M., Pereyra, M.J., Reed, N., Roberts, A., Sadler, K., Stavros, T., Tamura, R., Wood, K., Xu, P., Young, K., Alies, P., Badias, F., Baker, A., Bassi, M., Beam, C., Bounmananh, L., Bream, S., Deemer, M., Freeman, D., Gough, J., Ginem, J., Granger, M., Holloway, M., Kieffer, M., Lane, P., Law, P., Linton, C., Nallamshetty, L., Oduah, V., Parrimon, Y., Paulus, K., Pilger, J., Ramiro, J., Ritzie, A.Q.L., Sharma, A., Shor, A., Song, X.H., Terry, A., Weinberger, J., Wootten, M., Harding, M.F.P., McDonough, S., Mcgee, P.F., Hess, K.O., Phoebus, D., Quinlan, S., Raiden, E., Fradkin, J., Beck, G., Blumberg, E., Gubitosi-Klug, R., Laffel, L., Veatch, R., Wallace, D., Braun, J., Brillon, D., B. lo, Mitchell, H., Naji, A., Nerup, J., Orchard, T., Steffes, M., Tsiatis, A., Zinman, B., Loechelt, B., Baden, L., Green, M., Weinberg, A., Marcovina, S., Palmer, J.P., Yu, L.P., Shultz, A., Batts, E., Fitzpatrick, K., Ramey, M., Guerra, R., Webb, C., Caffey, F., Carr, L., Ergun-Longmire, B., Fenton, C., Giebner, D., Johnson, J., Maglionico, D., Marinelli, M., Martin, K., Minnozzi, E., Riley, W., Wilson, M., Gougeon, C., Ho, J., Huang, C., Pacaud, D., Virtanen, H., Craig, C., Ghatak, A., Henderson, T., Leyland, H., Padmore, K., Paul, P., Brickman, W., Halsey-Lyda, M., Petrie, P., Rizzo, D., Steuer, R., Suchyta, K., Torchen, L., Zimmerman, D., Bode, B., Dial, M., Gazaway, K., Hosey, R., Alkanani, A., Barker, J., Barr, M., Blau, A., Burdick, P., Burke, B., Chase, H., Drye, M., Escobar, E., Fitzgerald-Miller, L., Fouts, A., Gage, V., Gall, E., Goettle, H., Harris, S., Ketchum, K., King, M., Klingensmith, G., Lehr, D., Lehr, J., Lewis, L., Logsden-Sackett, N., Lykens, J., Maahs, D., Michels, A., Pelletier, S., Rihanek, M., Rodriguez, P., Schauwecker, A., Simmons, K., Smith, J., Steck, A., Tran, B., Tran, T., Wadwa, P., Wagner, R., Wright, H., Betancourt, J., Bui, V., DeSalvo, D., Gomez, D., Jake, K., Lynds, J., McCartney, T., McDonald, A., Pena, S., Pietropaolo, M., Greenbaum, C., Atkinson, M., Baidal, D., Battaglia, M., Becker, D., Bingley, P., Bosi, E., Buckner, J., Clements, M., Colman, P., Dimeglio, L., Evans-Molina, C., Gitelman, S., Goland, R., Gottlieb, P., Herold, K., Knip, M., Krischer, J., Lernmark, A., Moore, W., Moran, A., Muir, A., Palmer, J., Peakman, M., Philipson, L., Raskin, P., Redondo, M., Rodriguez, H., Russell, W., Spain, L., Schatz, D. A., Sosenko, J., Wherrett, D., Wilson, D., Winter, W., and Ziegler, A.

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Administration, Oral, 030209 endocrinology & metabolism, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Interquartile range, law, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, Family, Treatment Failure, Child, Original Investigation, Autoantibodies, Type 1 diabetes, Glucose tolerance test, medicine.diagnostic_test, business.industry, General Medicine, ta3121, Glucose Tolerance Test, medicine.disease, 030104 developmental biology, Diabetes Mellitus, Type 1, Child, Preschool, Cohort, Female, business, Follow-Up Studies
Abstract

Importance Type 1 diabetes requires major lifestyle changes and carries increased morbidity and mortality. Prevention or delay of diabetes would have major clinical effect. Objective To determine whether oral insulin delays onset of type 1 diabetes in autoantibody-positive relatives of patients with type 1 diabetes. Design, Setting, and Participants Between March 2, 2007, and December 21, 2015, relatives with at least 2 autoantibodies, including insulin autoantibodies and normal glucose tolerance, were enrolled in Canada, the United States, Australia, New Zealand, the United Kingdom, Italy, Sweden, Finland, and Germany. The main study group (n = 389) had first-phase insulin release on an intravenous glucose tolerance test that was higher than the threshold. The 55 patients in the secondary stratum 1 had an identical antibody profile as the main study group except they had first-phase insulin release that was lower than the threshold. Secondary strata 2 (n = 114) and strata 3 (n = 3) had different autoantibody profiles and first-phase insulin release threshold combinations. Follow-up continued through December 31, 2016. Interventions Randomization to receive 7.5 mg/d of oral insulin (n = 283) or placebo (n = 277), including participants in the main study group who received oral insulin (n = 203) or placebo (n = 186). Main Outcome and Measures The primary outcome was time to diabetes in the main study group. Significance was based on a 1-sided threshold of .05, and 1-sided 95% CIs are reported. Results Of a total of 560 randomized participants (median enrollment age, 8.2 years; interquartile range [IQR], 5.7-12.1 years; 170 boys [60%]; 90.7% white non-Hispanic; 57.6% with a sibling with type 1 diabetes), 550 completed the trial including 389 participants (median age, 8.4 years; 245 boys [63%]), 382 (96%) in the main study group. During a median follow-up of 2.7 years (IQR, 1.5-4.6 years) in the main study group, diabetes was diagnosed in 58 participants (28.5%) in the oral insulin group and 62 (33%) in the placebo group. Time to diabetes was not significantly different between the 2 groups (hazard ratio [HR], 0.87; 95% CI, 0-1.2;P = .21). In secondary stratum 1 (n = 55), diabetes was diagnosed in 13 participants (48.1%) in the oral insulin group and in 19 participants (70.3%) in the placebo group. The time to diabetes was significantly longer with oral insulin (HR, 0.45; 95% CI, 0-0.82;P = .006). The HR for time to diabetes for the between-group comparisons for the 116 participants in the other secondary stratum was 1.03 (95% CI, 0-2.11;P = .53) and for the entire cohort of 560 participants was 0.83 (95% CI, 0-1.07;P = .11), which were not significantly different. The most common adverse event was infection (n = 254), with 134 events in the oral insulin group and 120 events in the placebo group, but no significant study-related adverse events occurred. Conclusions and Relevance Among autoantibody-positive relatives of patients with type 1 diabetes, oral insulin at a dose of 7.5 mg/d, compared with placebo, did not delay or prevent the development of type 1 diabetes over 2.7 years. These findings do not support oral insulin as used in this study for diabetes prevention. Trial Registration clinicaltrials.gov Identifier:NCT00419562

Published
2017

10. Oxidative Stress and Cardiovascular Risk in Type 1 Diabetes Mellitus: Insights From the DCCT/EDIC Study

Author

Tang, W.H. Wilson, primary, McGee, Paula, additional, Lachin, John M., additional, Li, Daniel Y., additional, Hoogwerf, Byron, additional, Hazen, Stanley L., additional, Nathan, D.M., additional, Zinman, B., additional, Crofford, O., additional, Genuth, S., additional, Brown‐Friday, J., additional, Crandall, J., additional, Engel, H., additional, Engel, S., additional, Martinez, H., additional, Phillips, M., additional, Reid, M., additional, Shamoon, H., additional, Sheindlin, J., additional, Gubitosi‐Klug, R., additional, Mayer, L., additional, Pendegast, S., additional, Zegarra, H., additional, Miller, D., additional, Singerman, L., additional, Smith‐Brewer, S., additional, Novak, M., additional, Quin, J., additional, Genuth, Saul, additional, Palmert, M., additional, Brown, E., additional, McConnell, J., additional, Pugsley, P., additional, Crawford, P., additional, Dahms, W., additional, Gregory, N.S., additional, Lackaye, M.E., additional, Kiss, S., additional, Chan, R., additional, Orlin, A., additional, Rubin, M., additional, Brillon, D., additional, Reppucci, V., additional, Lee, T., additional, Heinemann, M., additional, Chang, S., additional, Levy, B., additional, Jovanovic, L., additional, Richardson, M., additional, Bosco, B., additional, Dwoskin, A., additional, Hanna, R., additional, Barron, S., additional, Campbell, R., additional, Bhan, A., additional, Kruger, D., additional, Jones, J.K., additional, Edwards, P.A., additional, Carey, J.D., additional, Angus, E., additional, Thomas, A., additional, Galprin, A., additional, McLellan, M., additional, Whitehouse, F., additional, Bergenstal, R., additional, Johnson, M., additional, Gunyou, K., additional, Thomas, L., additional, Laechelt, J., additional, Hollander, P., additional, Spencer, M., additional, Kendall, D., additional, Cuddihy, R., additional, Callahan, P., additional, List, S., additional, Gott, J., additional, Rude, N., additional, Olson, B., additional, Franz, M., additional, Castle, G., additional, Birk, R., additional, Nelson, J., additional, Freking, D., additional, Gill, L., additional, Mestrezat, W., additional, Etzwiler, D., additional, Morgan, K., additional, Aiello, L.P., additional, Golden, E., additional, Arrigg, P., additional, Asuquo, V., additional, Beaser, R., additional, Bestourous, L., additional, Cavallerano, J., additional, Cavicchi, R., additional, Ganda, O., additional, Hamdy, O., additional, Kirby, R., additional, Murtha, T., additional, Schlossman, D, additional, Shah, S., additional, Sharuk, G., additional, Silva, P., additional, Silver, P., additional, Stockman, M., additional, Sun, J., additional, Weimann, E., additional, Wolpert, H., additional, Aiello, L.M., additional, Jacobson, A., additional, Rand, L., additional, Rosenzwieg, J., additional, Larkin, M.E., additional, Christofi, M., additional, Folino, K., additional, Godine, J., additional, Lou, P., additional, Stevens, C., additional, Anderson, E., additional, Bode, H., additional, Brink, S., additional, Cornish, C., additional, Cros, D., additional, Delahanty, L., additional, eManbey, ., additional, Haggan, C., additional, Lynch, J., additional, McKitrick, C., additional, Norman, D., additional, Moore, D., additional, Ong, M., additional, Taylor, C., additional, Zimbler, D., additional, Crowell, S., additional, Fritz, S., additional, Hansen, K., additional, Gauthier‐Kelly, C., additional, Service, F.J., additional, Ziegler, G., additional, Barkmeier, A., additional, Schmidt, L., additional, French, B., additional, Woodwick, R., additional, Rizza, R., additional, Schwenk, W.F., additional, Haymond, M., additional, Pach, J., additional, Mortenson, J., additional, Zimmerman, B., additional, Lucas, A., additional, Colligan, R., additional, Luttrell, L., additional, Lopes‐Virella, M., additional, Caulder, S., additional, Pittman, C., additional, Patel, N., additional, Lee, K., additional, Nutaitis, M., additional, Fernandes, J., additional, Hermayer, K., additional, Kwon, S., additional, Blevins, A, additional, Parker, J., additional, Colwell, J., additional, Lee, D., additional, Soule, J., additional, Lindsey, P., additional, Bracey, M., additional, Farr, A., additional, Elsing, S., additional, Thompson, T., additional, Selby, J., additional, Lyons, T., additional, Yacoub‐Wasef, S., additional, Szpiech, M., additional, Wood, D., additional, Mayfield, R., additional, Molitch, M., additional, Adelman, D., additional, Colson, S., additional, Jampol, L., additional, Lyon, A., additional, Gill, M., additional, Strugula, Z., additional, Kaminski, L., additional, Mirza, R., additional, Simjanoski, E., additional, Ryan, D., additional, Johnson, C., additional, Wallia, A., additional, Ajroud‐Driss, S., additional, Astelford, P., additional, Leloudes, N., additional, Degillio, A., additional, Schaefer, B., additional, Mudaliar, S., additional, Lorenzi, G, additional, Goldbaum, M., additional, Jones, K., additional, Prince, M., additional, Swenson, M., additional, Grant, I., additional, Reed, R., additional, Lyon, R., additional, Kolterman, O., additional, Giotta, M., additional, Clark, T., additional, Friedenberg, G., additional, Sivitz, W.I., additional, Vittetoe, B., additional, Kramer, J., additional, Bayless, M., additional, Zeitler, R., additional, Schrott, H., additional, Olson, N., additional, Snetselaar, L., additional, Hoffman, R., additional, MacIndoe, J., additional, Weingeist, T., additional, Fountain, C., additional, Miller, R., additional, Johnsonbaugh, S., additional, Patronas, M., additional, Carney, M., additional, Mendley, S., additional, Salemi, P., additional, Liss, R., additional, Hebdon, M., additional, Counts, D., additional, Donner, T., additional, Gordon, J., additional, Hemady, R., additional, Kowarski, A., additional, Ostrowski, D., additional, Steidl, S., additional, Jones, B., additional, Herman, W.H., additional, Martin, C.L., additional, Pop‐Busui, R., additional, Greene, D.A., additional, Stevens, M.J., additional, Burkhart, N., additional, Sandford, T., additional, Floyd, J., additional, Bantle, J., additional, Flaherty, N., additional, Terry, J., additional, Koozekanani, D., additional, Montezuma, S., additional, Wimmergren, N., additional, Rogness, B., additional, Mech, M., additional, Strand, T., additional, Olson, J., additional, McKenzie, L., additional, Kwong, C., additional, Goetz, F., additional, Warhol, R., additional, Hainsworth, D., additional, Goldstein, D., additional, Hitt, S., additional, Giangiacomo, J., additional, Schade, D.S, additional, Canady, J.L., additional, Burge, M.R., additional, Das, A., additional, Avery, R.B., additional, Ketai, L.H., additional, Chapin, J.E., additional, Schluter, M.L., additional, Rich, J., additional, Johannes, C., additional, Hornbeck, D., additional, Schutta, M., additional, Bourne, P.A., additional, Brucker, A., additional, Braunstein, S., additional, Schwartz, S., additional, Maschak‐Carey, B.J., additional, Baker, L., additional, Orchard, T., additional, Cimino, L., additional, Songer, T., additional, Doft, B., additional, Olson, S., additional, Becker, D., additional, Rubinstein, D., additional, Bergren, R.L., additional, Fruit, J., additional, Hyre, R., additional, Palmer, C., additional, Silvers, N., additional, Lobes, L., additional, Rath, P. Paczan, additional, Conrad, P.W., additional, Yalamanchi, S., additional, Wesche, J., additional, Bratkowksi, M., additional, Arslanian, S., additional, Rinkoff, J., additional, Warnicki, J., additional, Curtin, D., additional, Steinberg, D., additional, Vagstad, G., additional, Harris, R., additional, Steranchak, L., additional, Arch, J., additional, Kelly, K., additional, Ostrosaka, P., additional, Guiliani, M., additional, Good, M., additional, Williams, T., additional, Olsen, K., additional, Campbell, A., additional, Shipe, C., additional, Conwit, R., additional, Finegold, D., additional, Zaucha, M., additional, Drash, A., additional, Morrison, A., additional, Malone, J.I., additional, Bernal, M.L., additional, Pavan, P.R., additional, Grove, N., additional, Tanaka, E.A., additional, McMillan, D., additional, Vaccaro‐Kish, J., additional, Babbione, L., additional, Solc, H., additional, DeClue, T.J., additional, Dagogo‐Jack, S., additional, Wigley, C., additional, Ricks, H., additional, Kitabchi, A., additional, Chaum, E., additional, Murphy, M.B., additional, Moser, S., additional, Meyer, D., additional, Iannacone, A., additional, Yoser, S., additional, Bryer‐Ash, M., additional, Schussler, S., additional, Lambeth, H., additional, Raskin, P., additional, Strowig, S., additional, Basco, M., additional, Cercone, S., additional, Barnie, A., additional, Devenyi, R., additional, Mandelcorn, M., additional, Brent, M., additional, Rogers, S., additional, Gordon, A., additional, Bakshi, N., additional, Perkins, B., additional, Tuason, L., additional, Perdikaris, F., additional, Ehrlich, R., additional, Daneman, D., additional, Perlman, K., additional, Ferguson, S, additional, Palmer, J., additional, Fahlstrom, R., additional, de Boer, I.H., additional, Kinyoun, J., additional, Van Ottingham, L., additional, Catton, S., additional, Ginsberg, J., additional, McDonald, C., additional, Harth, J., additional, Driscoll, M., additional, Sheidow, T., additional, Mahon, J., additional, Canny, C., additional, Nicolle, D., additional, Colby, P., additional, Dupre, J., additional, Hramiak, I., additional, Rodger, N.W., additional, Jenner, M., additional, Smith, T., additional, Brown, W., additional, May, M., additional, Lipps Hagan, J., additional, Agarwal, A., additional, Adkins, T., additional, Lorenz, R., additional, Feman, S., additional, Survant, L., additional, White, N.H., additional, Levandoski, L., additional, Grand, G., additional, Thomas, M., additional, Joseph, D., additional, Blinder, K., additional, Shah, G., additional, Burgess, D., additional, Boniuk, I., additional, Santiago, J., additional, Tamborlane, W., additional, Gatcomb, P., additional, Stoessel, K., additional, Ramos, P., additional, Fong, K., additional, Ossorio, P., additional, Ahern, J., additional, Meadema‐Mayer, L., additional, Beck, C., additional, Farrell, K., additional, Quin, J, additional, Gaston, P., additional, Trail, R., additional, Lachin, J., additional, Backlund, J., additional, Bebu, I., additional, Braffett, B., additional, Diminick, L., additional, Gao, X., additional, Hsu, W., additional, Klumpp, K., additional, Pan, H., additional, Trapani, V., additional, Cleary, P., additional, McGee, P., additional, Sun, W., additional, Villavicencio, S., additional, Anderson, K., additional, Dews, L., additional, Younes, Naji, additional, Rutledge, B., additional, Chan, K., additional, Rosenberg, D., additional, Petty, B., additional, Determan, A., additional, Kenny, D., additional, Williams, C., additional, Cowie, C., additional, Siebert, C., additional, Steffes, M., additional, Arends, V., additional, Bucksa, J., additional, Nowicki, M., additional, Chavers, B., additional, O'Leary, D., additional, Polak, J., additional, Harrington, A., additional, Funk, L., additional, Crow, R, additional, Gloeb, B., additional, Thomas, S., additional, O'Donnell, C., additional, Soliman, E.Z., additional, Zhang, Z.M., additional, Li, Y., additional, Campbell, C., additional, Keasler, L., additional, Hensley, S., additional, Hu, J., additional, Barr, M., additional, Taylor, T., additional, Prineas, R., additional, Feldman, E.L., additional, Albers, J.W., additional, Low, P., additional, Sommer, C., additional, Nickander, K., additional, Speigelberg, T., additional, Pfiefer, M., additional, Schumer, M., additional, Moran, M., additional, Farquhar, J., additional, Ryan, C., additional, Sandstrom, D., additional, Geckle, M., additional, Cupelli, E., additional, Thoma, F., additional, Burzuk, B., additional, Woodfill, T., additional, Danis, R., additional, Blodi, B., additional, Lawrence, D., additional, Wabers, H., additional, Gangaputra, S., additional, Neill, S., additional, Burger, M., additional, Dingledine, J., additional, Gama, V., additional, Sussman, R., additional, Davis, M., additional, Hubbard, L., additional, Budoff, M., additional, Darabian, S., additional, Rezaeian, P., additional, Wong, N., additional, Fox, M., additional, Oudiz, R., additional, Kim, L, additional, Detrano, R., additional, Cruickshanks, K., additional, Dalton, D., additional, Bainbridge, K., additional, Lima, J., additional, Bluemke, D., additional, Turkbey, E., additional, der Geest, ., additional, Liu, C., additional, Malayeri, A., additional, Jain, A., additional, Miao, C., additional, Chahal, H., additional, Jarboe, R., additional, Monnier, V., additional, Sell, D., additional, Strauch, C., additional, Hazen, S., additional, Pratt, A., additional, Tang, W., additional, Brunzell, J., additional, Purnell, J., additional, Natarajan, R., additional, Miao, F., additional, Zhang, L., additional, Chen, Z., additional, Paterson, A., additional, Boright, A., additional, Bull, S., additional, Sun, L., additional, Scherer, S., additional, Lyons, T.J., additional, Jenkins, A., additional, Klein, R., additional, Virella, G., additional, Jaffa, A., additional, Carter, R., additional, Stoner, J., additional, Garvey, W.T., additional, Lackland, D., additional, Brabham, M., additional, McGee, D., additional, Zheng, D., additional, Mayfield, R.K., additional, Maynard, J., additional, Wessells, H., additional, Sarma, A, additional, Dunn, R., additional, Holt, S., additional, Hotaling, J., additional, Kim, C., additional, Clemens, Q., additional, Brown, J., additional, and McVary, K., additional

Published
2018
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12. Bardoxolone Methyl in Type 2 Diabetes and Stage 4 Chronic Kidney Disease

Author

De Zeeuw, Dick, Akizawa, Tadao, Audhya, Paul, Bakris, George L., Chin, Melanie, Christ-Schmidt, Heidi, Goldsberry, Angie, Houser, Mark, Krauth, Melissa, Lambers Heerspink, Hiddo J., McMurray, John J., Meyer, Colin J., Parving, Hans-Henrik, Remuzzi, Giuseppe, Toto, Robert D., Vaziri, Nosratola D., Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, Chertow, Glenn M., Toto, B., McCullough, P., Ivanovich, P., Ketteler, M., Lachin, J., McGill, J., Agarwal, R., Anker, S., Arenillas, J. F., Januzzi, J., Jardine, A., Kasner, S., Kissela, B., Kolansky, D., Mann, J., Thadhani, R., Champion de Crespigny, P., Chan, D. T., D'Almeida, E., Fraser, I., Gray, N., Holt, S., Irish, A., Isbel, N., Kerr, P., Packham, D., Phoon, R., Pollock, C., Roger, S., Suranyi, M., Walker, R., Wittert, G., Yue, D., Balcke, P., Prager, R., Schernthaner, G., Sunder-Plassmann, G., Jadoul, M., Krzesinski, J. M., Peeters, P., Van der Niepen, P., Van Gaal, L., Van Vlem, B., Warling, X., Chow, S., Cournoyer, S., Dumas, R., Jolly, S., Levin, A., McMahon, A., Mehta, H., Ooi, T. C., Perkins, D., Roy, L., Sapir, D., Tam, P., Bartaskova, D., Hemzsky, L., Kubina, D., Szabo, M., Tesar, V., Combe, C., Faller, B., Fauvel, J. P., Halimi, J. M., Hourmant, M., Le Meur, Y., Urena-Torres, P., Zaoui, P., Al-Sarraf, S., Burst, V., Degenhardt, S., Kempe, H. P., Kleophas, W., Kosch, C., Krumme, B., Kuhlmann, M., Pistrosch, F., Rambausek, M., Schmidt-Guertler, H., Segiet, T., Sommerer, C., Vielhauer, V., Wanner, C., Beberashvili, I., Benchetrit, S., Herskovits, T., Karnieli, E., Levin-Iaina, N., Mosenzon, O., Tsur, A., van Dijk, D. J., Wainstein, J., Yagil, Y., Yerushalmi, Y., Colussi, G., Conte, G., Di Luca, M., Giovambatista, C., Messa, P., Pani, A., Pisani, A., Rapana, M. R., Ruggenenti, P., Villa, G., Zoccali, C., Correa-Rotter, R., Diaz-Escobedo, S. L., Garcia, P., Gonzalez Galvez, G., Obrador Vera, G. T., Rico, R., Calero, F., Cigarran, S., de Alvaro, F., de Francisco, A. L., Egido, J., Fernandez, E., Fernandez Vega, F., Fort, J., Galan Serrano, A., Gorriz Teruel, J. L., Martinez, I., Martinez Castelao, A., Munar, M. A., Navarro, J., Nieto, J., Osuna, A., Pascual, J., Portoles, J., Praga, M., Vallés, M., Fellstrom, B., Frisenette-Fich, C., Hadimeri, H., Stenvinkel, P., Svensson, M., Weiss, L., Adamson, K., Dornhorst, A., El Kossi, M., Gnudi, L., Hendry, B., Johnson, A., Joseph, F., Kalra, P., Marshall, S., Mikhail, A., Myint, K. S., Soran, H., Taal, M., Zehnder, D., Abbott, L., Acharya, A., Ahmed, Z., Aiello, J., Akom, M., Ali, S., Alzohaili, O., Anderson, L., Anderson, S., Anger, M., Appel, G., Arakaki, R. F., Arif, A., Assefi, A. R., Atray, N., Awad, A., Barranco, E., Belledonne, M. O., Belo, D., Bernardo, M., Bernstein, R., Bhalla, V., Bhatia, D., Black, R. M., Block, G., Blondin, J., Blumenthal, S. S., Bononi, P., Brantley, R. R., Bresssler, P., Broumand, V., Brusco, O., Buerkert, J., Burgos-Calderon, R., Campbell, R., Canas, G., Cangiano, J., Cherlin, R., Chilakapati, V., Comunale, R., Coyne, D., Crawford, P. W., Darwish, R., Deeb, W., Denker, P. S., Desai, S., Desouza, C., Diamond, S., Dixon, B. S., Durham, J. H., Eisner, G., Elder, J. G., El-Shahawy, M., Fadda, G., Fitz-Patrick, D., Fonseca, V., Fraser, N. J., Frei, G., Fried, L., Galindo-Ramos, E., Germain, M., Ghantous, W., Gilbert, J. M., Gillum, D., Godwin, J., Goel, A., Goldfarb, DS., Graf, R. J., Greenwood, T., Guasch, A., Hanna, A., Harper, K., Herman, T., Hilton, T., Hines, T., Hoggard, J., Hootkins, R., Huseman, R., Israelit, A., Jamal, A., Kant, K., Kaptein, E., Kathresal, A., Kaupke, J., Kaveh, K., Kaye, W., Keightley, G. E., Keith, K., Khairullah, Q., Kondle, V., Kopyt, N., Krishna, G., Lawrence, M. K., LeBeau, M., Leehey, D. J., Levine, M. M., Levinson, D., Lew, S. Q., Lewis, D., Linfert, D., Liss, K., Lund, R., Madeleine, P., Mahmood, K., Martin, E. R., Martinez, C., Mayeda, S. O., Mendez, R., Middleton, J., Molitch, M. E., Moncrief, J., Moustafa, M., Muoneke, R., Murray, A. V., Murugan, T. S., Nammour, T. M., Nassar, G., Navaneethan, S., Newman, J., Nossuli, A., Nwakoby, I., Osama, S., Ouseph, R., Parker, J., Parnes, E., Patel, N., Pergola, P., Perlman, A., Perry, R. G., Petrillo, R., Prabhakar, S., Purighalla, R. S., Quesada-Suarez, L., Rabiei, A., Raskin, P., Rastogi, A., Reisin, E., Rekhi, A., Rivera-Colon, L., Rizk, D., Rodelas, R., Roer, D., Rosas, S., Ross, D. L., Rovner, S., Sackel, H., Sader, S., Santos, P., Schmidt, R., Shafik, S., Shakeel, M., Sharon, Z., Silva, A. L., Silva, A., Singh, B., Smith, M., Solomon, R., Soman, S., Spinowitz, B., Sprague, S. M., Spry, L., Stonesifer, L., Streja, D., Suchinda, P., Sun, C., Thakar, C. V., Trespalacios, F., Tumlin, J. A., Van Buren, P., Vernace, M., Vicks, S., Warren, M., Weiss, D., Welker, J., Winston, J. A., Wombolt, D. G., Wood, M., Wu, M., Wynne, A., Yu, H., Zabaneh, R. I., Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), De Zeeuw, Dick, Akizawa, Tadao, Audhya, Paul, Bakris, George L., Chin, Melanie, Christ-Schmidt, Heidi, Goldsberry, Angie, Houser, Mark, Krauth, Melissa, Lambers Heerspink, Hiddo J., Mcmurray, John J., Meyer, Colin J., Parving, Hans-Henrik, Remuzzi, Giuseppe, Toto, Robert D., Vaziri, Nosratola D., Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, Chertow, Glenn M., Toto, B., Mccullough, P., Ivanovich, P., Ketteler, M., Lachin, J., Mcgill, J., Agarwal, R., Anker, S., Arenillas, J. F., Januzzi, J., Jardine, A., Kasner, S., Kissela, B., Kolansky, D., Mann, J., Thadhani, R., Champion de Crespigny, P., Chan, D. T., D'Almeida, E., Fraser, I., Gray, N., Holt, S., Irish, A., Isbel, N., Kerr, P., Packham, D., Phoon, R., Pollock, C., Roger, S., Suranyi, M., Walker, R., Wittert, G., Yue, D., Balcke, P., Prager, R., Schernthaner, G., Sunder-Plassmann, G., Jadoul, M., Krzesinski, J. M., Peeters, P., Van der Niepen, P., Van Gaal, L., Van Vlem, B., Warling, X., Chow, S., Cournoyer, S., Dumas, R., Jolly, S., Levin, A., Mcmahon, A., Mehta, H., Ooi, T. C., Perkins, D., Roy, L., Sapir, D., Tam, P., Bartaskova, D., Hemzsky, L., Kubina, D., Szabo, M., Tesar, V., Combe, C., Faller, B., Fauvel, J. P., Halimi, J. M., Hourmant, M., Le Meur, Y., Urena-Torres, P., Zaoui, P., Al-Sarraf, S., Burst, V., Degenhardt, S., Kempe, H. P., Kleophas, W., Kosch, C., Krumme, B., Kuhlmann, M., Pistrosch, F., Rambausek, M., Schmidt-Guertler, H., Segiet, T., Sommerer, C., Vielhauer, V., Wanner, C., Beberashvili, I., Benchetrit, S., Herskovits, T., Karnieli, E., Levin-Iaina, N., Mosenzon, O., Tsur, A., van Dijk, D. J., Wainstein, J., Yagil, Y., Yerushalmi, Y., Colussi, G., Conte, G., Di Luca, M., Giovambatista, C., Messa, P., Pani, A., Pisani, A., Rapana, M. R., Ruggenenti, P., Villa, G., Zoccali, C., Correa-Rotter, R., Diaz-Escobedo, S. L., Garcia, P., Gonzalez Galvez, G., Obrador Vera, G. T., Rico, R., Calero, F., Cigarran, S., de Alvaro, F., de Francisco, A. L., Egido, J., Fernandez, E., Fernandez Vega, F., Fort, J., Galan Serrano, A., Gorriz Teruel, J. L., Martinez, I., Martinez Castelao, A., Munar, M. A., Navarro, J., Nieto, J., Osuna, A., Pascual, J., Portoles, J., Praga, M., Vallés, M., Fellstrom, B., Frisenette-Fich, C., Hadimeri, H., Stenvinkel, P., Svensson, M., Weiss, L., Adamson, K., Dornhorst, A., El Kossi, M., Gnudi, L., Hendry, B., Johnson, A., Joseph, F., Kalra, P., Marshall, S., Mikhail, A., Myint, K. S., Soran, H., Taal, M., Zehnder, D., Abbott, L., Acharya, A., Ahmed, Z., Aiello, J., Akom, M., Ali, S., Alzohaili, O., Anderson, L., Anderson, S., Anger, M., Appel, G., Arakaki, R. F., Arif, A., Assefi, A. R., Atray, N., Awad, A., Barranco, E., Belledonne, M. O., Belo, D., Bernardo, M., Bernstein, R., Bhalla, V., Bhatia, D., Black, R. M., Block, G., Blondin, J., Blumenthal, S. S., Bononi, P., Brantley, R. R., Bresssler, P., Broumand, V., Brusco, O., Buerkert, J., Burgos-Calderon, R., Campbell, R., Canas, G., Cangiano, J., Cherlin, R., Chilakapati, V., Comunale, R., Coyne, D., Crawford, P. W., Darwish, R., Deeb, W., Denker, P. S., Desai, S., Desouza, C., Diamond, S., Dixon, B. S., Durham, J. H., Eisner, G., Elder, J. G., El-Shahawy, M., Fadda, G., Fitz-Patrick, D., Fonseca, V., Fraser, N. J., Frei, G., Fried, L., Galindo-Ramos, E., Germain, M., Ghantous, W., Gilbert, J. M., Gillum, D., Godwin, J., Goel, A., Goldfarb, Ds., Graf, R. J., Greenwood, T., Guasch, A., Hanna, A., Harper, K., Herman, T., Hilton, T., Hines, T., Hoggard, J., Hootkins, R., Huseman, R., Israelit, A., Jamal, A., Kant, K., Kaptein, E., Kathresal, A., Kaupke, J., Kaveh, K., Kaye, W., Keightley, G. E., Keith, K., Khairullah, Q., Kondle, V., Kopyt, N., Krishna, G., Lawrence, M. K., Lebeau, M., Leehey, D. J., Levine, M. M., Levinson, D., Lew, S. Q., Lewis, D., Linfert, D., Liss, K., Lund, R., Madeleine, P., Mahmood, K., Martin, E. R., Martinez, C., Mayeda, S. O., Mendez, R., Middleton, J., Molitch, M. E., Moncrief, J., Moustafa, M., Muoneke, R., Murray, A. V., Murugan, T. S., Nammour, T. M., Nassar, G., Navaneethan, S., Newman, J., Nossuli, A., Nwakoby, I., Osama, S., Ouseph, R., Parker, J., Parnes, E., Patel, N., Pergola, P., Perlman, A., Perry, R. G., Petrillo, R., Prabhakar, S., Purighalla, R. S., Quesada-Suarez, L., Rabiei, A., Raskin, P., Rastogi, A., Reisin, E., Rekhi, A., Rivera-Colon, L., Rizk, D., Rodelas, R., Roer, D., Rosas, S., Ross, D. L., Rovner, S., Sackel, H., Sader, S., Santos, P., Schmidt, R., Shafik, S., Shakeel, M., Sharon, Z., Silva, A. L., Silva, A., Singh, B., Smith, M., Solomon, R., Soman, S., Spinowitz, B., Sprague, S. M., Spry, L., Stonesifer, L., Streja, D., Suchinda, P., Sun, C., Thakar, C. V., Trespalacios, F., Tumlin, J. A., Van Buren, P., Vernace, M., Vicks, S., Warren, M., Weiss, D., Welker, J., Winston, J. A., Wombolt, D. G., Wood, M., Wu, M., Wynne, A., Yu, H., Zabaneh, R. I., de Zeeuw, D, Akizawa, T, Audhya, P, Bakris, Gl, Chin, M, Christ Schmidt, H, Goldsberry, A, Houser, M, Krauth, M, Lambers Heerspink, Hj, Mcmurray, Jj, Meyer, Cj, Parving, Hh, Remuzzi, G, Toto, Rd, Vaziri, Nd, Wanner, C, Wittes, J, Wrolstad, D, Chertow, Gm, Pisani, Antonio, De Zeeuw, D, Bakris, G, Lambers Heerspink, H, Mcmurray, J, Meyer, C, Parving, H, Toto, R, Vaziri, N, and Chertow, G.

Subjects
Male, medicine.medical_specialty, Intention to Treat Analysi, NF-E2-Related Factor 2, NEPHROPATHY, Urology, Renal function, Kaplan-Meier Estimate, Type 2 diabetes, Placebo, Article, Nephropathy, NRF2, Double-Blind Method, Cardiovascular Disease, Diabetes mellitus, Internal medicine, medicine, CKD, Treatment Failure, Bardoxolone methyl, Oleanolic Acid, Renal Insufficiency, Chronic, Aged, OUTCOMES, IRBESARTAN, ANALOGS, business.industry, Medicine (all), Hazard ratio, General Medicine, Middle Aged, medicine.disease, Weight Lo, Endocrinology, Diabetes Mellitus, Type 2, Diabetic Nephropathie, Kidney Failure, Chronic, Female, TRIAL, Stage 4 chronic kidney disease, business, Glomerular Filtration Rate, Human, RENAL EVENTS BEACON
Abstract

Background: Although inhibitors of the renin–angiotensin–aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)–related factor 2 activators further reduce this risk is unknown. Methods: We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to < 30 ml per minute per 1.73 m2 of body-surface area) to bardoxolone methyl, at a daily dose of 20 mg, or placebo. The primary composite outcome was end-stage renal disease (ESRD) or death from cardiovascular causes. Results: The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring committee; the median follow-up was 9 months. A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl and 69 of 1097 (6%) randomly assigned to placebo had a primary composite outcome (hazard ratio in the bardoxolone methyl group vs. the placebo group, 0.98; 95% confidence interval [CI], 0.70 to 1.37; P=0.92). In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes. A total of 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died from heart failure, as compared with 55 in the placebo group (hazard ratio, 1.83; 95% CI, 1.32 to 2.55; P < 0.001). Estimated GFR, blood pressure, and the urinary albumin-to-creatinine ratio increased significantly and body weight decreased significantly in the bardoxolone methyl group, as compared with the placebo group. Conclusions: Among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease, bardoxolone methyl did not reduce the risk of ESRD or death from cardiovascular causes. A higher rate of cardiovascular events with bardoxolone methyl than with placebo prompted termination of the trial. (Funded by Reata Pharmaceuticals; BEACON ClinicalTrials.gov number, NCT01351675.)

Published
2013

14. Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease

Author

De Zeeuw, D, Akizawa, T, Audhya, P, Bakris, GL, Chin, M, Christ-Schmidt, H, Goldsberry, A, Houser, M, Krauth, M, Lambers Heerspink, HJ, McMurray, JJ, Meyer, CJ, Parving, HH, Remuzzi, G, Toto, RD, Vaziri, ND, Wanner, C, Wittes, J, Wrolstad, D, Chertow, GM, Toto, B, McCullough, P, Ivanovich, P, Ketteler, M, Lachin, J, McGill, J, Agarwal, R, Anker, S, Arenillas, JF, Januzzi, J, Jardine, A, Kasner, S, Kissela, B, Kolansky, D, Mann, J, Thadhani, R, Champion de Crespigny, P, Chan, DT, D'Almeida, E, Fraser, I, Gray, N, Holt, S, Irish, A, Isbel, N, Kerr, P, Packham, D, Phoon, R, Pollock, C, Roger, S, Suranyi, M, Walker, R, Wittert, G, Yue, D, Balcke, P, Prager, R, Schernthaner, G, Sunder-Plassmann, G, Jadoul, M, Krzesinski, JM, Peeters, P, Van der Niepen, P, Van Gaal, L, Van Vlem, B, Warling, X, Chow, S, Cournoyer, S, Dumas, R, Jolly, S, Levin, A, McMahon, A, Mehta, H, Ooi, TC, Perkins, D, Roy, L, Sapir, D, Tam, P, Bartaskova, D, Hemzsky, L, Kubina, D, Szabo, M, Tesar, V, Combe, C, Faller, B, Fauvel, JP, Halimi, JM, Hourmant, M, Le Meur, Y, Urena-Torres, P, Zaoui, P, Al-Sarraf, S, Burst, V, Degenhardt, S, Kempe, HP, Kleophas, W, Kosch, C, Krumme, B, Kuhlmann, M, Pistrosch, F, and Rambausek, M

Abstract

BACKGROUND: Although inhibitors of the renin-angiotensin-aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)-related factor 2 activators further reduce this risk is unknown. METHODS: We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to

Published
2013

15. Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes

Author

Greenbaum, C J, Mandrup-Poulsen, T, McGee Friedenberg, P, Battelino, T, Haastert, B, Ludvigsson, J, Pozzilli, P, Lachin, J M, Kolb, H, and University of Zurich

Subjects
2712 Endocrinology, Diabetes and Metabolism, 2724 Internal Medicine, 2902 Advanced and Specialized Nursing, 10265 Clinic for Endocrinology and Diabetology, 610 Medicine & health
Published
2008
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20. Baseline characteristics of participants enrolled in the empagliflozin cardiovascular outcome trial (EMPA-REG OUTCOME™) in patients with type 2 diabetes

Author

Zinman, B, primary, Inzucchi, S, additional, Lachin, J, additional, Wanner, C, additional, Ferrari, R, additional, Fitchett, D, additional, Bluhmki, E, additional, Kempthorne-Rawson, J, additional, Newman, J, additional, Johansen, OE, additional, Woerle, HJ, additional, and Broedl, UC, additional

Published
2014
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22. Evaluation of in-stent restenosis in the APPROACH trial (assessment on the prevention of progression by Rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history)

Author

Garcia-Garcia, H.M. (Hector), Garg, S.A. (Scot), Brugaletta, S. (Salvatore), Morocutti, G. (Giorgio), Ratner, R.E. (Robert), Kolatkar, N.S. (Nikheel), Kravitz, B.G. (Barbara), Miller, D.M. (Diane), Huang, C. (Chunmei), Nesto, R.W. (Richard), Serruys, P.W.J.C. (Patrick), Aftring, R.P. (R.), Wolstenholme, J. (Jane), Saarinen, J. (Jari), Fowler, R. (R.), Hoffman, J. (Jonathan), Steele-Norwood, D. (D.), Russell, R. (Robert), Young, S. (S.), Chou, Y.F., McMorn, S. (Steve), Kirsch, C. (Courtney), Louridas, B. (Bonnie), Olivieria, T. (Teresa), Mattioli, D. (Debra), Miller, D. (D.), Nguyen, C. (C.), Jahnke, K. (Kristoph), Mintz, G.S. (Gary), Lachin, J. (J.), Abrahamson, M. (M.), Carson, P. (P.), Jones, P. (Peter), Garcia-Garcia, H.M. (Hector), Garg, S.A. (Scot), Brugaletta, S. (Salvatore), Morocutti, G. (Giorgio), Ratner, R.E. (Robert), Kolatkar, N.S. (Nikheel), Kravitz, B.G. (Barbara), Miller, D.M. (Diane), Huang, C. (Chunmei), Nesto, R.W. (Richard), Serruys, P.W.J.C. (Patrick), Aftring, R.P. (R.), Wolstenholme, J. (Jane), Saarinen, J. (Jari), Fowler, R. (R.), Hoffman, J. (Jonathan), Steele-Norwood, D. (D.), Russell, R. (Robert), Young, S. (S.), Chou, Y.F., McMorn, S. (Steve), Kirsch, C. (Courtney), Louridas, B. (Bonnie), Olivieria, T. (Teresa), Mattioli, D. (Debra), Miller, D. (D.), Nguyen, C. (C.), Jahnke, K. (Kristoph), Mintz, G.S. (Gary), Lachin, J. (J.), Abrahamson, M. (M.), Carson, P. (P.), and Jones, P. (Peter)

Abstract

To determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) in patients with T2DM and coronary artery disease. A total of 462 patients with T2DM were randomized to rosiglitazone or glipizide for up to 18 months in the APPROACH trial, and had evaluable baseline and follow-up IVUS examinations. There was no significant difference in the size of plaque behind stent between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (-5.6 mm 3 vs. 1.9 mm 3; P = 0.61) or with a drug-eluting stent (12.1mm 3 vs. 5.5 mm 3; P = 0.09). Similarly, there was no significant difference in pe

Published
2012
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24. Response to Cundy

Author

Nathan, D. M., primary, Davis, M., additional, Cleary, P., additional, and Lachin, J., additional

Published
2001
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25. Skin collagen glycation, glycoxidation, and crosslinking are lower in subjects with long-term intensive versus conventional therapy of type 1 diabetes: relevance of glycated collagen products versus HbA1c as markers of diabetic complications. DCCT Skin Collagen Ancillary Study Group. Diabetes Control and Complications Trial.

Author

Monnier, V M, primary, Bautista, O, additional, Kenny, D, additional, Sell, D R, additional, Fogarty, J, additional, Dahms, W, additional, Cleary, P A, additional, Lachin, J, additional, and Genuth, S, additional

Published
1999
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27. Remission of nephrotic range proteinuria in type I diabetes

Author

Hebert, Lee A., primary, Bain, Raymond P., additional, Verme, Dante, additional, Cattran, Daniel, additional, Whittier, Frederick C., additional, Tolchin, Nathan, additional, Rohde, Richard D., additional, Lewis, Edmund J., additional, Lewis, E.J., additional, Rohde, R., additional, Nemcek, M., additional, Hunsicker, L.G., additional, Bain, R.P., additional, Lachin, J., additional, Greenhouse, S.W., additional, Verme, DA., additional, Turlington, T.R., additional, Burrows, P.K., additional, Wish, J., additional, Sheehan, J., additional, Pohl, M., additional, Berl, T., additional, Santiago, G., additional, Lemann, J., additional, Blumenthal, S., additional, Bresnahan, B.A., additional, Hebert, L., additional, Nahman, N.S., additional, Goldfarb, S., additional, Kobrin, S., additional, Rodby, R., additional, Lietz, S., additional, Valaitis, D., additional, McLaughlin), A. Levey and M., additional, Williams, M., additional, McGill, J., additional, Whittier, F., additional, Cattran, D., additional, Hano, J., additional, Maxwell, D., additional, Porush, J., additional, Spitalewitz, S., additional, Shapiro, K., additional, Adler, S., additional, Tolchin, N., additional, Hoy, W., additional, Bernstein, R., additional, Svetkey, L., additional, Sharon, Z., additional, Rosenbaum, B., additional, Anolik, J.R., additional, Tidesley, H., additional, Joyce, C., additional, and Breyer, J., additional

Published
1994
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28. Levels of oxidized LDL and advanced glycation end products-modified LDL in circulating immune complexes are strongly associated with increased levels of carotid intima-media thickness and its progression in type 1 diabetes.

Author

Lopes-Virella MF, Hunt KJ, Baker NL, Lachin J, Nathan DM, Virella G, Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group, Lopes-Virella, Maria F, Hunt, Kelly J, Baker, Nathaniel L, Lachin, John, Nathan, David M, and Virella, G

Abstract

Objective: High cholesterol levels in circulating immune complexes (IC), surrogate markers of modified LDL, are associated with increased carotid intima-media thickness (IMT) and cardiovascular events in type 1 diabetes. Different modifications of LDL are involved in IC formation, but which of these are predictive of vascular events is not known. Therefore, we measured oxidized LDL (oxLDL), advanced glycation end products-modified LDL (AGE-LDL), and malondialdehyde-modified LDL (MDA-LDL) in IC and determined their relationship with increased carotid IMT and compared the strength of the association with that observed with conventional risk factors.Research Design and Methods: Levels of oxLDL, AGE-LDL, and MDA-LDL were measured in circulating IC isolated from sera of 479 patients of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort, collected at baseline. Internal and common carotid IMT were measured 8 and 14 years later by DCCT/EDIC.Results: OxLDL, AGE-LDL, and MDA-LDL levels in circulating IC were significantly correlated with diabetes duration, BMI, and lipid and blood pressure, but not with age. Multivariate logistic regression models indicated that individuals in the highest versus lowest quartile of oxLDL and AGE-LDL in IC had a 6.11-fold [confidence interval (CI) 2.51-14.8] and a 6.4-fold (CI 2.53-16.2) increase in the odds of having high carotid IMT, respectively, after adjusting for conventional risk factors. Parallel analyses resulted in odds ratios of 2.62 (CI 1.24, 5.55) for LDL-C, 1.45 (CI 0.69, 3.03) for diastolic blood pressure, and 2.33 (CI 1.09, 4.99) for A1C.Conclusions: OxLDL and AGE-LDL in circulating IC were significantly associated with progression and increased levels of carotid IMT in type 1 diabetes. [ABSTRACT FROM AUTHOR]

Published
2011
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31. Progression and remission of renal disease in the Lupus Nephritis Collaborative Study. Results of treatment with prednisone and short-term oral cyclophosphamide.

Author

Levey, Andrew S., Shu-Ping Lan, Corwin, Howard L., Kasinath, Batakuntalam S., Lachin, John, Neilson, Eric G., Hunsicker, Lawrence G., Lewis, Edmund J., Levey, A S, Lan, S P, Corwin, H L, Kasinath, B S, Lachin, J, Neilson, E G, Hunsicker, L G, and Lewis, E J

Subjects
KIDNEY diseases, LUPUS nephritis, ANALYSIS of variance, COMBINATION drug therapy, CHRONIC kidney failure, CLINICAL trials, COMBINED modality therapy, COMPARATIVE studies, CREATININE, DRUG administration, RESEARCH methodology, MEDICAL cooperation, ORAL drug administration, PLASMAPHERESIS, PREDNISONE, PROGNOSIS, RESEARCH, RESEARCH funding, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, DISEASE remission, CYCLOPHOSPHAMIDE, DISEASE complications
Abstract

Objective: To describe the clinical course of severe lupus nephritis and to identify the risk factors for progression to renal failure among patients treated with prednisone and short-term courses of low-dose oral cyclophosphamide.Design: Ancillary analyses of data from the Lupus Nephritis Collaborative Study (LNCS).Setting: University hospital medical centers (14).Patients: The 86 patients who participated in the LNCS (mean follow-up, 136 weeks [2.6 years]) and a subgroup of 63 patients with follow-up of more than 48 weeks (mean follow-up, 160 weeks [3.1 years]).Measurements: Initial clinical and pathologic features, response to therapy within 48 weeks, and subsequent clinical events, including development of renal failure.Main Results: Renal failure developed in 18 patients (21%). An observed elevation in serum creatinine concentration was the only initial feature predictive of subsequent renal failure. Mean (+/- SD) initial serum creatinine levels were higher in patients who subsequently developed renal failure (244 +/- 134 mumol/L [2.76 +/- 1.52 mg/dL] compared with 163 +/- 103 mumol/L [1.85 +/- 1.17 mg/dL]; P = 0.007). The risk for renal failure was higher among patients with initial serum creatinine levels greater than 106 mumol/L (1.2 mg/dL) (29% compared with 6.5%; P = 0.014). Response to therapy (defined as resolution of initial serum creatinine elevations within 48 weeks) refined the prognosis based on initial serum creatinine determinations. The risk for subsequent renal failure was higher among patients who failed to respond to therapy within 48 weeks (30% compared with 0%; P = 0.015). By comparison, 9% of patients with normal initial serum creatinine levels progressed to renal failure after 48 weeks.Conclusions: Initial serum creatinine levels and responses to initial therapy with prednisone and short-term cyclophosphamide, as used in the LNCS, can guide further therapy. Patients with normal initial serum creatinine levels or resolution of initial serum creatinine elevations within 48 weeks have a low risk for renal failure and may not require long-term treatment with cyclophosphamide. [ABSTRACT FROM AUTHOR]

Published
1992
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32. Chenodiol (chenodeoxycholic acid) for dissolution of gallstones: the National Cooperative Gallstone Study. A controlled trial of efficacy and safety.

Author

Schoenfield, Leslie J., Lachin, John M., Schoenfield, L J, and Lachin, J M

Subjects
CHENODEOXYCHOLIC acid, GALLSTONES
Abstract

A double-masked study was conducted to determine the efficacy and safety of randomly allocated chenodiol (chenodeoxycholic acid, 750 mg/d or 350 mg/d) or placebo administered for 2 years to 916 patients for dissolution of radiolucent gallstones. There was confirmed complete dissolution in 13.5% of patients (750 mg/d), 5.2% (375 mg/d), and 0.8% (placebo), p less than 0.0001. Partial (over 50%) or complete dissolution (by validated roentgenographic metrology) occurred in 40.8% (750 mg/d), 23.6% (375 mg/d), and 11.0% (placebo), p less than 0.0001. Dissolution occurred more frequently in women, thin patients, or patients with small or floating gallstones or serum cholesterol greater than or equal to 227 mg/dL. Clinically significant hepatotoxicity occurred in 3% of patients (750 mg/d), 0.4% (375 mg/d), and 0.4% (placebo), p less than 0.007, and always was reversible biochemically. Elevations of 10% or more of serum cholesterol, mostly low-density lipoproteins, occurred in 85.2% of patients (750 mg/d), 82.8% (375 mg/d), and 67.0% (placebo), p less than 0.001. Chenodiol, 750 mg/d for up to 2 years, is appropriate therapy for dissolution of gallstones in selected patients who are informed of the risks and benefits. [ABSTRACT FROM AUTHOR]

Published
1981
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39. Newborn Offspring of a Schizophrenic Parent: Cardiac Reactivity to Auditory Stimuli.

Author

Schachter, J., Kerr, J., Lachin, J. M., and Faer, M.

Subjects
PEOPLE with schizophrenia, DELIVERY (Obstetrics), HEART beat, NEWBORN infants, AUDITORY perception, POSTNATAL care
Abstract

Heart rate level and phasic responses to auditory stimuli were recorded in a total of 39 newborn offspring with one schizophrenic parent and compared to those of 82 newborns with no family history of a schizophrenic disorder as well as to those of 48 newborns with a possible family history of a schizophrenic disorder. Newborns were tested for 3½ hrs on the second and, again, on the third postnatal day, and the data were analyzed in relation to a number of perinatal variables. Results indicated a significant Interaction between diagnostic group and the level of maternal delivery medication for the change in heart rate level during the second, but not the third, postnatal day. The possible validity of this finding is discussed, and reasons for the failure to obtain more definitive heart rate differences between these groups of newborns are considered. [ABSTRACT FROM AUTHOR]

Published
1975
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43. A genome-wide association study of diabetic kidney disease in subjects with type 2 diabetes

Author

van Zuydam, Natalie R, Ahlqvist, Emma, Sandholm, Niina, Deshmukh, Harshal, Rayner, N William, Abdalla, Moustafa, Ladenvall, Claes, Ziemek, Daniel, Fauman, Eric, Robertson, Neil R, Mckeigue, Paul M, Valo, Erkka, Forsblom, Carol, Harjutsalo, Valma, Perna, Annalisa, Rurali, Erica, Marcovecchio, M Loredana, Igo, Robert P, Salem, Rany M, Perico, Norberto, Lajer, Maria, Käräjämäki, Annemari, Imamura, Minako, Kubo, Michiaki, Takahashi, Atsushi, Sim, Xueling, Liu, Jianjun, van Dam, Rob M, Jiang, Guozhi, Tam, Claudia H T, Luk, Andrea O Y, Lee, Heung Man, Lim, Cadmon K P, Szeto, Cheuk Chun, Wing Yee, So, Chan, Juliana C N, Ang, Su Fen, Dorajoo, Rajkumar, Wang, Ling, Clara, Tan Si Hua, Mcknight, Amy-Jayne, Duffy, Seamus, Pezzolesi, Marcus G, Marre, Michel, Gyorgy, Beata, Hadjadj, Samy, Hiraki, Koivula, S, Uggeldahl, T, Forslund, T, Halonen, A, Koistinen, A, Koskiaho, P, Laukkanen, M, Saltevo, J, Tiihonen, M, Forsen, M, Granlund, H, Jonsson, Ac, Nyroos, B, Kinnunen, P, Orvola, A, Salonen, T, Vähänen, A, Paldanius, Kr, Riihelä, M, Ryysy, L, Laukkanen, Kh, Nyländen, P, Sademies, A, Anderson, S, Asplund, B, Byskata, U, Liedes, P, Kuusela, M, Virkkala, T, Nikkola, A, Ritola, E, Niska, Tm, Saarinen, H, Oukko-Ruponen, Se, Virtanen, T, Lyytinen, Va, Kari, Ph, Simonen, T, Kaprio, Sa, Kärkkäinen, J, Rantaeskola, B, Kääriäinen, Tp, Haaga, J, Pietiläinen, Al, Klemetti, S, Nyandoto, T, Rontu, E, Satuli-Autere, S, Toivonen, Kr, Lansimaki, Hv, Ahonen, R, Ivaska-Suomela, M, Jauhiainen, A, Laine, Mm, Pellonpää, T, Puranen, R, Airas, Ma, Laakso, J, Rautavaara, K, Erola, Rm, Jatkola, E, Lönnblad, Tr, Malm, A, Mäkelä, J, Rautamo, E, Hentunen, P, Lagerstam, J, Feodoroff, M, Gordin, D, Heikkilä, O, Hietala, K, Fagerudd, J, Korolainen, M, Kyllönen, L, Kytö, J, Lindh, S, Pettersson-Fernholm, K, Rosengård-Bärlund, M, Sandelin, A, Thorn, L, Tuomikangas, J, Vesisenaho, T, Wadén, J, Sipilä, V, Kalliomäki, Ft, Koskelainen, J, Nikkanen, R, Savolainen, N, Sulonen, H, Valtonen, E, Norvio, L, Hämäläinen, A, Toivanen, E, Parta, Ja, Pirttiniemi, I, Aranko, S, Ervasti, S, Kauppinen-Mäkelin, R, Kuusisto, A, Leppälä, T, Nikkilä, K, Pekkonen, L, Jokelainen, Ks, Kananen, K, Karjalainen, M, Kemppainen, P, Mankinen, Am, Reponen, A, Sankari, M, Suominen, P, Lappalainen, A, Liimatainen, M, Santaholma, J, Aimolahti, A, Huovinen, E, Ilkka, V, Lehtimäki, M, Pälikkö-Kontinen, E, Vanhanen, A, Koskinen, E, Siitonen, T, Huttunen, E, Ikäheimo, R, Karhapää, P, Kekäläinen, P, Laakso, M, Lakka, T, Lampainen, E, Moilanen, L, Tanskanen, S, Niskanen, L, Tuovinen, U, Vauhkonen, I, Voutilainen, E, Rcw, Ma, Chan, Jcn, Huang, Y, Lan, Hy, Lok, S, Tomlinson, B, Tsui, Skw, Yu, W, Yip, Kyl, Chan, Tf, Fan, X, So, Wy, Szeto, Cc, Tang, N, Luk, Ao, Tian, X, Jiang, G, Tam, Cht, Lee, Hm, Lim, Ckp, Chan, Kkh, Xie, F, Acw, Ng, Cheung, Gpy, Yeung, Mw, Mai, S, Zhang, S, Yu, P, Weng, M, Maxwell, Ap, Mcknight, Aj, Savage, Da, Walker, J, Thomas, S, Viberti, Gc, Boulton, Ajm, Marshall, S, Demaine, Ag, Millward, Ba, Bain, Sc, Sandholm, N, Forsblom, C, Harjutsalo, V, Mäkinen, Vp, Ahola, Aj, Dahlström, E, Lehto, M, Lithovius, R, Panduru, Nm, Parkkonen, M, Saraheimo, M, Söderlund, J, Soro-Paavonen, A, Syreeni, A, Thorn, Lm, Tolonen, N, Groop, Ph, Mckay, Gj, Salem, Rm, Isakova, T, Palmer, C, Guiducci, C, Taylor, A, Mirel, Db, Williams, Ww, Hirschhorn, Jn, Florez, Jc, Brennan, Ep, Sadlier, Dm, Martin, F, Godson, C, Mayer, L, Gubitosi-Klug, R, Bourne, P, Schutta, M, Lackaye, Me, Gregory, Ns, Kruger, D, Jones, Jk, Bhan, A, Golden, E, Aiello, L, Larkin, M, Nathan, D, Ziegler, G, Caulder, S, Pittman, C, Luttrell, L, Lopes-Virella, M, Johnson, M, Gunyou, K, Bergenstal, R, Vittetoe, B, Sivitz, W, Flaherty, N, Bantle, J, Hitt, S, Goldstein, D, Hainsworth, D, Cimino, L, Orchard, T, Wigley, C, Dagogo-Jack, S, Strowig, S, Raskin, P, Barnie, A, Zinman, B, Fahlstrom, R, Palmer, J, Harth, J, Driscoll, M, Mcdonald, C, Lipps Hagan, J, May, M, Levandoski, L, White, N, Gatcomb, P, Tamborlane, W, Adelman, D, Colson, S, Molitch, M, Lorenzi, G, Mudaliar, S, Johnsonbaugh, S, Miller, R, Canady, J, Schade, D, Bernal, Ml, Malone, J, Morrison, A, Martin, C, Herman, W, Pop-Busui, R, Cowie, C, Leschek, E, Cleary, P, Lachin, J, Braffett, B, Steffes, M, Arends, V, Blodi, B, Danis, R, Lawrence, D, Wabers, H, Soliman, E, Zhang, Zm, Campbell, C, Hensley, S, Keasler, L, Mark, M, Albertini, M, Boustany, C, Ehlgen, A, Gerl, M, Huber, J, Schölch, C, Zimdahl-Gelling, H, Groop, L, Agardh, E, Ahlqvist, E, Ajanki, T, Al Maghrabi, N, Almgren, P, Apelqvist, J, Bengtsson, E, Berglund, L, Björckbacka, H, Blom-Nilsson, U, Borell, M, Burström, A, Cilio, C, Cinthio, M, Dreja, K, Dunér, P, Engelbertsen, D, Fadista, J, Gomez, M, Goncalves, I, Hedblad, B, Hultgårdh, A, Johansson, Me, Kennbäck, C, Kravic, J, Ladenvall, C, Lernmark, Å, Lindholm, E, Ling, C, Luthman, H, Melander, O, Neptin, M, Nilsson, J, Nilsson, P, Nilsson, T, Nordin, G, Orho-Melander, M, Ottoson-Laakso, E, Persson, A, Persson, M, Persson, Må, Postma, J, Pranter, E, Rattik, S, Sterner, G, Tindberg, L, Wigren, M, Zetterqvist, A, Åkerlund, M, Ostling, G, Kanninen, T, Ahonen-Bishopp, A, Eliasson, A, Herrala, T, Tikka-Kleemola, P, Hamsten, A, Betsholtz, C, Björkholm, A, Foroogh, F, Genové, G, Gertow, K, Gigante, B, He, B, Leander, K, Mcleod, O, Nastase-Mannila, M, Patrakka, J, Silveira, A, Strawbridge, R, Tryggvason, K, Vikström, M, Ohrvik, J, Österholm, Am, Thorand, B, Gieger, C, Grallert, H, Ludwig, T, Nitz, B, Schneider, A, Wang-Sattler, R, Zierer, A, Remuzzi, G, Benigni, A, Donadelli, R, Lesti, Md, Noris, M, Perico, N, Perna, A, Piras, R, Ruggenenti, P, Rurali, E, Dunger, D, Chassin, L, Dalton, N, Deanfield, J, Horsford, J, Rice, C, Rudd, J, Walker, N, Whitehead, K, Wong, M, Colhoun, H, Adams, F, Akbar, T, Belch, J, Deshmukh, H, Dove, F, Ellingford, A, Farran, B, Ferguson, M, Henderson, G, Houston, G, Khan, F, Leese, G, Liu, Y, Livingstone, S, Looker, H, Mccann, M, Mcgurnaghan, S, Morris, A, Newton, D, Pearson, E, Reekie, G, Smith, N, Shore, A, Aizawa, K, Ball, C, Bellenger, N, Casanova, F, Frayling, T, Gates, P, Gooding, K, Hattersley, A, Ling, R, Mawson, D, Shandas, R, Strain, D, Thorn, C, Smith, U, Hammarstedt, A, Häring, H, Pedersen, O, Sesti, G, Fagerholm, E, Toppila, I, Valo, E, Salomaa, V, Havulinna, A, Kristiansson, K, Okamo, P, Peltola, T, Perola, M, Pietilä, A, Ripatti, S, Taimi, M, Ylä-Herttuala, S, Babu, M, Dijkstra, M, Gurzeler, E, Huusko, J, Kholová, I, Merentie, M, Poikolainen, M, Mccarthy, M, Groves, C, Juliusdottir, T, Karpe, F, Lagou, V, Rayner, W, Robertson, N, van Zuydam, N, Cobelli, C, Di Camillo, B, Finotello, F, Sambo, F, Toffolo, G, Trifoglio, E, Bellazzi, R, Barbarini, N, Bucalo, M, Larizza, C, Magni, P, Malovini, A, Marini, S, Mulas, F, Quaglini, S, Sacchi, L, Vitali, F, Ferrannini, E, Boldrini, B, Kozakova, M, Mari, A, Morizzo, C, Mota, L, Natali, A, Palombo, C, Venturi, E, Walker, M, Patrono, C, Pagliaccia, F, Rocca, B, Nuutila, P, Haukkala, J, Knuuti, J, Roivainen, A, Saraste, A, Mckeague, P, Colombo, M, Steckel-Hamann, B, Bokvist, K, Shankar, S, Thomas, M, Gan, Lm, Heinonen, S, Jönsson-Rylander, Ac, Momo, R, Schnecke, V, Unwin, R, Walentinsson, A, Whatling, C, Nogoceke, E, Pacheco, Gd, Formentini, I, Schindler, T, Tortoli, P, Bassi, L, Boni, E, Dallai, A, Guidi, F, Lenge, M, Matera, R, Ramalli, A, Ricci, S, Viti, J, Jablonka, B, Crowther, D, Gassenhuber, J, Hess, S, Hubschle, T, Juretschke, Hp, Rutten, H, Sadowski, T, Wohlfart, P, Brosnan, J, Clerin, V, Fauman, E, Hyde, C, Malarstig, A, Pullen, N, Tilley, M, Tuthill, T, Vangjeli, C, Linda T, Ziemek D., Ahluwalia, Tarunveer S, Almgren, Peter, Schulz, Christina-Alexandra, Orho-Melander, Marju, Linneberg, Allan, Christensen, Cramer, Witte, Daniel R, Grarup, Niels, Brandslund, Ivan, Melander, Olle, Paterson, Andrew D, Tregouet, David, Maxwell, Alexander P, Lim, Su Chi, Ronald C W, Ma, Tai, E Shyong, Maeda, Shiro, Lyssenko, Valeriya, Tuomi, Tiinamaija, Krolewski, Andrzej S, Rich, Stephen S, Hirschhorn, Joel N, Florez, Jose C, Dunger, David, Pedersen, Oluf, Hansen, Torben, Rossing, Peter, Remuzzi, Giuseppe, Brosnan, Mary Julia, Palmer, Colin N A, Groop, Per-Henrik, Colhoun, Helen M, Groop, Leif C, Mccarthy, Mark, I, Palombo, Carlo, Clinicum, Diabetes and Obesity Research Program, Research Programs Unit, Nefrologian yksikkö, Department of Medicine, Institute for Molecular Medicine Finland, Tiinamaija Tuomi Research Group, Endokrinologian yksikkö, Per Henrik Groop / Principal Investigator, Leif Groop Research Group, HUS Abdominal Center, HUS Internal Medicine and Rehabilitation, and Lee Kong Chian School of Medicine (LKCMedicine)

Subjects
0301 basic medicine, Male, endocrine system diseases, Endocrinology, Diabetes and Metabolism, LOCI, Genome-wide association study, Type 2 diabetes, Bioinformatics, Kidney Failure, 0302 clinical medicine, Genome-wide analysis, 80 and over, Diabetic Nephropathies, Renal Insufficiency, Chronic, Genome-wide analysis, Type 2 Diabetes, Aged, 80 and over, RISK, INSULIN-RESISTANCE, diabetes, Diabetes, STAGE RENAL-DISEASE, Single Nucleotide, Middle Aged, Type 2 Diabetes, SUSCEPTIBILITY GENES, Adult, Aged, Case-Control Studies, Diabetes Mellitus, Type 2, Female, Genetic Predisposition to Disease, Genome-Wide Association Study, Humans, Kidney Failure, Chronic, Polymorphism, Single Nucleotide, Renal Insufficiency, Chronic, OBESITY, BIOLOGICAL PATHWAYS, nephropathy, Medical genetics, Type 2, kidney, medicine.medical_specialty, Diabetic Nephropathies/epidemiology, Settore BIO/14 - FARMACOLOGIA, Renal Insufficiency, Chronic/complications, NEPHROPATHY, SNP, 030209 endocrinology & metabolism, Nephropathy, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Diabetes mellitus, Journal Article, Diabetes Mellitus, Internal Medicine, medicine, Medicine [Science], Polymorphism, Diabetic Kidney Disease, METAANALYSIS, Genetic heterogeneity, business.industry, Diabetes Mellitus, Type 2/complications, association, Case-control study, nutritional and metabolic diseases, Kidney Failure, Chronic/complications, FAT DISTRIBUTION, medicine.disease, 030104 developmental biology, 3121 General medicine, internal medicine and other clinical medicine, Microalbuminuria, genetic, business
Abstract

Identification of sequence variants robustly associated with predisposition to diabetic kidney disease (DKD) has the potential to provide insights into the pathophysiological mechanisms responsible. We conducted a genome-wide association study (GWAS) of DKD in type 2 diabetes (T2D) using eight complementary dichotomous and quantitative DKD phenotypes: the principal dichotomous analysis involved 5,717 T2D subjects, 3,345 with DKD. Promising association signals were evaluated in up to 26,827 subjects with T2D (12,710 with DKD). A combined T1D+T2D GWAS was performed using complementary data available for subjects with T1D, which, with replication samples, involved up to 40,340 subjects with diabetes (18,582 with DKD). Analysis of specific DKD phenotypes identified a novel signal near GABRR1 (rs9942471, P = 4.5 × 10-8) associated with microalbuminuria in European T2D case subjects. However, no replication of this signal was observed in Asian subjects with T2D or in the equivalent T1D analysis. There was only limited support, in this substantially enlarged analysis, for association at previously reported DKD signals, except for those at UMOD and PRKAG2, both associated with estimated glomerular filtration rate. We conclude that, despite challenges in addressing phenotypic heterogeneity, access to increased sample sizes will continue to provide more robust inference regarding risk variant discovery for DKD. ASTAR (Agency for Sci., Tech. and Research, S’pore) NMRC (Natl Medical Research Council, S’pore)

44. Rationale and Design of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)

Author

Buse, J. B., Kahn, S. E., Staten, M., Larkin, M. E., Nathan, D. M., Lachin, J. M., Krause-Steinrauf, H., and Wexler, D.

Subjects
endocrine system diseases, nutritional and metabolic diseases, 3. Good health
Abstract

OBJECTIVEThe epidemic of type 2 diabetes (T2DM) threatens to become the major public health problem of this century. However, a comprehensive comparison of the long-term effects of medications to treat T2DM has not been conducted. GRADE, a pragmatic, unmasked clinical trial, aims to compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.RESEARCH DESIGN AND METHODSGRADE was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The consensus protocol was approved by NIDDK and the GRADE Research Group. Eligibility criteria for the 5,000 metformin-treated subjects include 7.5% (58 mmol/mol) and, ultimately, the need to implement an intensive basal/bolus insulin regimen. The four drugs will also be compared with respect to selected microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness.CONCLUSIONSGRADE will compare the long-term effectiveness of major glycemia-lowering medications and provide guidance to clinicians about the most appropriate medications to treat T2DM. GRADE begins recruitment at 37 centers in the U.S. in 2013.

49. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.

Author

Diabetes Control and Complications Trial Research Group, Nathan, D M, Genuth, S, Lachin, J, Cleary, P, Crofford, O, Davis, M, Rand, L, and Siebert, C

Abstract

Background: Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.Methods: A total of 1441 patients with IDDM--726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.Results: In the primary-prevention cohort, intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent (95 percent confidence interval, 62 to 85 percent), as compared with conventional therapy. In the secondary-intervention cohort, intensive therapy slowed the progression of retinopathy by 54 percent (95 percent confidence interval, 39 to 66 percent) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent (95 percent confidence interval, 14 to 67 percent). In the two cohorts combined, intensive therapy reduced the occurrence of microalbuminuria (urinary albumin excretion of > or = 40 mg per 24 hours) by 39 percent (95 percent confidence interval, 21 to 52 percent), that of albuminuria (urinary albumin excretion of > or = 300 mg per 24 hours) by 54 percent (95 percent confidence interval 19 to 74 percent), and that of clinical neuropathy by 60 percent (95 percent confidence interval, 38 to 74 percent). The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia.Conclusions: Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM. [ABSTRACT FROM AUTHOR]

Published
1993

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