Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments group lifestyle, metformin, boost lifestyle
Phase phase 3
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date September 2002
End date October 2013
Trial size 2776 participants
Trial identifier NCT00038727, IND - DK048489, NCT00353314

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). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.

The DPPOS 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 IFG/IGT 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Boost / Lifestyle, previously Intensive Lifestyle during the DPP
group lifestyle
Quarterly group lifestyle sessions
boost lifestyle
In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
(Active Comparator)
Metformin / Lifestyle, previously the metformin treatment group during DPP
group lifestyle
Quarterly group lifestyle sessions
metformin Glucophage
Administered as 850mg twice per day
(Placebo Comparator)
Group Lifestyle, previously placebo treated participants during DPP
group lifestyle
Quarterly group lifestyle sessions

Primary Outcomes

Measure
development of diabetes.
time frame: 2008
Prevalence of aggregate microvascular complication
time frame: 2012-2013

Secondary Outcomes

Measure
Microvascular and cardiovascular disease risk factors
time frame: 2013
Aging related outcomes - Cognitive and Physical Function
time frame: 2010 and 2012
Subclinical atherosclerosis
time frame: 2012
Quality of life and economic analyses
time frame: 2002-2013

Eligibility Criteria

Male or female participants at least 25 years old.

Participation as a volunteer in the DPP.

Additional Information

Official title Diabetes Prevention Program Outcomes Study
Principal investigator Marinella Temprosa, PhD
Description The current DPPOS Executive Summary and protocol, as well as DPP protocol and lifestyle manuals and publications are available at: http://www.bsc.gwu.edu/dpp/index.htmlvdoc
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).