Diabetes Prevention Program Outcomes Study

Phase 3 Completed NCT00038727

Summary

The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study rete

Number of Participants With Diabetes.

Outcomes were assessed from 1996-2020 for median follow-up of 21 years and a maximum follow-up of 23 years including a median of 3 years in DPP in all participants enrolled in DPPOS. · Participants

Prevalence of Aggregate Microvascular Complication

Outcomes were assessed from 2012-2013 (approximately 2 years). · average percentage of participants

Number of Participants With Total Cancer Except Non-melanoma Skin Cancer

Outcomes were assessed from 1996-2020 (approximately 24 years). · Participants

Open in BENITIONS View on ClinicalTrials.gov

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