Diabetes Prevention Program Outcomes Study

Last updated: December 3, 2021
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Cancer

Treatment

N/A

Clinical Study ID

NCT00038727
DPPOS
U01DK048489
  • Ages > 25
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Participation as a volunteer in the Diabetes Prevention Program (DPP).

Study Design

Total Participants: 2779
Study Start date:
September 01, 2002
Estimated Completion Date:
January 31, 2025

Study 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

Connect with a study center

  • George Washington University

    Rockville, Maryland 20852
    United States

    Site Not Available

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