NCT00038727

Diabetes Prevention Program Outcomes Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,779 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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 retention and adherence (\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.

Detailed description

The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: http://www.dppos.org

Conditions

• Diabetes Mellitus
• Cancer
• CVD

Interventions

Type	Name	Description
BEHAVIORAL	DPPOS Group Lifestyle	Quarterly group lifestyle sessions
DRUG	Metformin	Administered as 850mg twice per day, masked in DPP and open label in DPPOS
BEHAVIORAL	DPPOS Boost Lifestyle	In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
BEHAVIORAL	Intensive Lifestyle Group Session	16 session curriculum in group format. In DPP delivered to ILS as individual sessions

Timeline

• Start date: 2002-09-01
• Primary completion: 2024-10-01
• Completion: 2025-01-01
• First posted: 2002-06-05
• Last updated: 2021-12-28
• Results posted: 2017-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study