DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Diabetes Prevention Program (DPP) was a multi-center controlled clinical trial examining the efficacy of an intensive lifestyle intervention or Metformin to prevent or delay the development of diabetes in a population selected to be at high risk due to the presence of impaired glucose intolerance (IGT). Development of diabetes, defined by the 1997 ADA criteria, was the primary outcome while cardiovascular disease and its risk factors were important secondary outcomes. On the basis of a statistically significant and clinically compelling decrease in the development of diabetes in the lifestyle intervention and the Metformin treated groups (58% and 31% reduction in hazards respectively) compared with the placebo treated group the DPP Data Monitoring Board and NIDDK ended the masked treatment phase of the study August 2001, one year earlier than originally planned. The DPP addressed its primary objective, establishing the efficacy of lifestyle modification and Metformin in decreasing the incidence of diabetes in an ethnically diverse population at high risk for an average of 2.8 years; however, many important issues remained unanswered. The Diabetes Prevention Program Outcomes Study (DPPOS) is a prospective study of the effects of DPP interventions on continued prevention or delay of diabetes, and on preventing or ameliorating its complications, specifically cardiovascular disease and diabetic microangiopathy. The rationale for the overall design is to provide maintenance of therapies found to be effective in DPP, to assess the long-term impacts on diabetes prevention and complications. All participants will be followed for five years, with a total mean follow-up of approximately 9 years from the beginning of DPP.