The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group.
Authors: G. A. Bray, I. W. Culbert, C. M. Champagne, L. Dawson, B. Eberhardt, F. L. Greenway, F. G. Guillory, A. A. Hebert, M. L. Jeffirs, B. M. Kennedy, J. C. Lovejoy, L. E. Melancon, L. H. Morris, J. Perault, D. H. Ryan, D. A. Sanford, K. G. Smith, L. L. Smith, J. A. St. Amant, E. Tucker, R. T. Tulley, P. C. Vicknair, D. Williamson, J. J. Zachwieja, J. A. Tobian, M. J. Matulik, B. Clarke, D. A. Collins, K. B. Czech, C. DeSandre, D. A. Ehrmann, G. Geiger, B. Harding-Clay, R. M. Hilbrich, W. L. McNabb, K. S. Polonsky, A. R. Semenske, K. A. Stepp, Pamela G Watson, J. T. Mendoza, K. A. Smith, B. J. Goldstein, C. Lark, R. Liberoni, L. Murphy, C. Pepe, J. M. Spandorfer, R. B. Goldberg, P. Rowe, J. Calles, P. Casanova, R. P. Donahue, H. J. Florez, A. Giannella, V. McLymont, J. Mendez, P. O'Hara, J. Ojito, R. Prineas, S. M. Haffner, M. G. Montez, H. Miettinen, C. M. Mobley, L. A. Mykkanen, M. M. Rozek, R. F. Hamman, P. V. Nash, B. N. Calonge, J. O. Hill, S. R. Hoyer, B. T. Jortberg, M. Miller-Stone, J. G. Regensteiner, H. Seagle, S. C. Steinke, L. Testaverde, B. Van-Dorsten, E. S. Horton, K. E. Lawton, R. A. Arky, M. Bryant, J. P. Burke, E. Caballero, K. M. Callaghan, O. P. Ganda, T. Franklin, S. D. Jackson, A. M. Jacobsen, L. M. Kula, M. Kocal, M. A. Malloy, M. Nicosia, C. F. Oldmixon, J. Pan, M. Quitingon, S. Rubtchinsky, E. W. Seely, D. Schweizer
Journal: Diabetes Care (2000)

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 &amp;gt; or = 25 years, BMI &amp;gt; or = 24 kg/m2 (&amp;gt; or = 22 kg/m2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 5.3-6.9 mmol/l (or &amp;lt; 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 &amp;lt; 40 years of age, and 20% were &amp;gt; 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 &amp;gt; 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.