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he Biostatistics Center serves as the Data Coordinating Center for the Diabetes Prevention Program Outcomes Study (DPPOS), a multi-center clinical trial of the primary prevention of diabetes. The DPP was a partially double-masked, placebo- controlled, randomized clinical trial designed to evaluate the safety and efficacy of intensive lifestyle intervention (7% loss of body weight and an increase in calorie expenditure of at least 700 kcal per week) and pharmacological intervention (the biguanide metformin) on the prevention of diabetes in participants with impaired glucose tolerance (IGT). Over a three-year period in 27 U.S. clinical sites, DPP enrolled 3,234 participants with IGT. Participants were randomized to one of three treatment groups: placebo, metformin, or intensive lifestyle intervention. Randomized participants were followed for two to five years with quarterly visits. The study found that the lifestyle intervention reduced the risk of developing diabetes by 58% over a 3-year period (New England Journal of Medicine, February 2002). The corresponding risk reduction for metformin was 31%. The DPP Collaborative Group was funded to conduct continued follow-up of the DPP cohort for an additional five years to evaluate the effects of the interventions on further development of diabetes and diabetes complications, including retinopathy, microangiopathy, and cardiovascular disease. Funding by NIDDK (U01-DK-048489), 1994-2008; IND 49,782.