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The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group.

2000; American Diabetes Association; Volume: 23; Issue: 11 Linguagem: Inglês

10.2337/diacare.23.11.1619

1935-5548

George A. Bray, Iris W. Culbert, Catherine M. Champagne, Linda Dawson, Barbara Eberhardt, Frank L. Greenway, Fonda G. Guillory, Adelaide A. Hebert, Michael L. Jeffirs, Betty M. Kennedy, Jennifer C. Lovejoy, Lee E. Melancon, Laura H. Morris, J. Perault, Donna H. Ryan, Deborah A. Sanford, Kenneth G. C. Smith, Leland L. Smith, Julia A. St. Amant, Elizabeth W. Tucker, Richard T. Tulley, Paula C. Vicknair, David F. Williamson, J. J. Zachwieja, Janet Tobian, Margaret J. Matulik, B.L. Clarke, David Collins, Kirsten Czech, Catherine DeSandre, David A. Ehrmann, G. Geiger, Barbara Harding-Clay, Ruthanne Hilbrich, Wylie McNabb, K. S. Polonsky, Ann R. Semenske, K. Amy Stepp, Pamela G. Watson, John Mendoza, Karen Smith, B. J. Goldstein, Chris Lark, Renee Liberoni, Leigh C. Murphy, Constance Pepe, John Spandorfer, Ronald Goldberg, Patricia M. Rowe, J. Calles, P Casanova, Richard P. Donahue, Hermes Flórez, Anna Giannella, V. McLymont, José D. Méndez, Patrick J. O’Hara, Juliet Ojito, Ronald J. Prineas, Steven M. Haffner, Maria G. Montez, H. Miettinen, C. Mobley, L. Mykkanen, M. M. Rozek, Richard F. Hamman, Patricia V. Nash, B. Ned Calonge, James O. Hill, Shelley R. Hoyer, Bonnie T. Jortberg, M. Miller-Stone, Judith G. Regensteiner, Helen Seagle, Sheila C. Steinke, Lisa Testaverde, Brent VanDorsten, Edward S. Horton, Kathleen E. Lawton, Ronald A. Arky, Marsha Bryant, J. P. Burke, Esther Lagunas Caballero, Kimberley Callaghan, Om P Ganda, Thainara Araújo Franklin, Steven Jackson, A. M. Jacobsen, Lyn M. Kula, Margaret Kocal, Maureen A. Malloy, M Nicosia, Cathryn F. Oldmixon, Jocelyn Pan, Marizel Quitingon, Stacy Rubtchinsky, Ellen W. Seely, Daniela Schweizer,

Pharmacology and Obesity Treatment

OBJECTIVE: The Diabetes Prevention Program (DPP) is a 27-center randomized clinical trial designed to evaluate the safety and efficacy of interventions that may delay or prevent development of diabetes in people at increased risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: Eligibility requirements were age > or = 25 years, BMI > or = 24 kg/m2 (> or = 22 kg/m2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 5.3-6.9 mmol/l (or < or = 6.9 mmol for American Indians). Randomization of participants into the DPP over 2.7 years ended in June 1999. Baseline data for the three treatment groups--intensive lifestyle modification, standard care plus metformin, and standard care plus placebo--are presented for the 3,234 participants who have been randomized. RESULTS: Of all participants, 55% were Caucasian, 20% were African-American, 16% were Hispanic, 5% were American Indian, and 4% were Asian-American. Their average age at entry was 51 +/- 10.7 years (mean +/- SD), and 67.7% were women. Moreover, 16% were < 40 years of age, and 20% were > or = 60 years of age. Of the women, 48% were postmenopausal. Men and women had similar frequencies of history of hypercholesterolemia (37 and 33%, respectively) or hypertension (29 and 26%, respectively). On the basis of fasting lipid determinations, 54% of men and 40% of women fit National Cholesterol Education Program criteria for abnormal lipid profiles. More men than women were current or former cigarette smokers or had a history of coronary heart disease. Furthermore, 66% of men and 71% of women had a first-degree relative with diabetes. Overall, BMI averaged 34.0 +/- 6.7 kg/m2 at baseline with 57% of the men and 73% of women having a BMI > or = 30 kg/m2. Average fasting plasma glucose (6.0 +/- 0.5 mmol/l) and HbA1c (5.9 +/- 0.5%) in men were comparable with values in women (5.9 +/- 0.4 mmol/l and 5.9 +/- 0.5%, respectively). CONCLUSIONS: The DPP has successfully randomized a large cohort of participants with a wide distribution of age, obesity, and ethnic and racial backgrounds who are at high risk for developing type 2 diabetes. The study will examine the effects of interventions on the development of diabetes.