Lifestyle Changes + Metformin for Diabetes Prevention
(DPPOS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
David M Nathan, MD
Principal Investigator
Massachusetts General Hospital
Medha Munshi, MD
Principal Investigator
Joslin Diabetes Center
David M. Nathan, MD
Principal Investigator
Massachusetts General Hospital
Barbara Linder, MD, PhD
Principal Investigator
NIDDK Project Scientist
Kishore Gadde, MD
Principal Investigator
Pennington Biomedical Research Center
David Ehrmann, MD
Principal Investigator
University of Chicago
Kevin Furlong, MD
Principal Investigator
Jefferson Medical College of Thomas Jefferson University
Samuel Dagogo-Jack, MD, MB
Principal Investigator
University of Tennessee
Marinella Temprosa, PhD
Principal Investigator
George Washington University Biostatistics Center
Mark Molitch, MD
Principal Investigator
Northwestern University
Happy Araneta, PhD,MPH
Principal Investigator
University of California, San Diego
Sherita Hill Golden, MD, MHS
Principal Investigator
Johns Hopkins School of Medicine
David S Schade, MD
Principal Investigator
The University of New Mexico
Santica M Marcovina, PhD
Principal Investigator
University of Washington
Sunder Mudaliar, MD
Principal Investigator
University of California, San Diego
F. Xavier Pi-Sunyer, MD
Principal Investigator
Columbia University
Jill Crandall, MD
Principal Investigator
Albert Einstein College of Medicine
Christine Lee, MD
Principal Investigator
NIDDK Project Scientist
Steven Kahn, MB, ChB
Principal Investigator
University of Washington
Kieren J Mather, MD
Principal Investigator
Indiana University
Michelle Magee, MD
Principal Investigator
Medstar Health Research Institute
Elizabeth Venditti, PhD
Principal Investigator
University of Pittsburgh
Marjerie Mau, MD
Principal Investigator
University of Hawaii
William Knowler, MD
Principal Investigator
SW Indian Center, NIDDK
Karol E Watson, MD
Principal Investigator
University of California, Los Angeles
Angela Brown, MD
Principal Investigator
Washington University School of Medicine
Kathleen Jablonski, PhD
Principal Investigator
George Washington University Biostatistics Center
Ronald B Goldberg, MD
Principal Investigator
University of Miami
Helen P Hazuda, MD
Principal Investigator
The University of Texas Health Science Center at San Antonio
Dana Dabelea, MD, PhD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for volunteers who were part of the Diabetes Prevention Program, focusing on those at high risk due to impaired glucose tolerance. It's particularly aimed at understanding long-term health outcomes in diverse populations, including a significant minority representation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants were randomized to either intensive lifestyle intervention or metformin treatment during the original DPP trial
DPPOS Phase 1 and 2
Participants continued with either open-label metformin or lifestyle interventions, with additional group sessions
DPPOS-3
Long-term follow-up to examine effects of metformin on cardiovascular disease and cancer outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DPPOS Boost Lifestyle
- DPPOS Group Lifestyle
- Intensive Lifestyle Group Session
- Metformin
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
Indian Health Service (IHS)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute on Aging (NIA)
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
National Cancer Institute (NCI)
Collaborator
National Eye Institute (NEI)
Collaborator
National Center for Research Resources (NCRR)
Collaborator
Office of Research on Women's Health (ORWH)
Collaborator