Diabetes Prevention Program Outcomes 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.

Conditions

• Diabetes Mellitus
• Cancer
• CVD

Interventions

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute on Aging (NIA)

  collaborator NIH

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• National Eye Institute (NEI)

  collaborator NIH

• National Center for Research Resources (NCRR)

  collaborator NIH

• Office of Research on Women's Health (ORWH)

  collaborator NIH

• Centers for Disease Control and Prevention

  collaborator FED

• American Diabetes Association

  collaborator OTHER

• Indian Health Service (IHS)

  collaborator FED

• General Clinical Research Program

  collaborator UNKNOWN

• US Department of Veterans Affairs

  collaborator FED

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• David M. Nathan, MD · Massachusetts General Hospital

• Marinella Temprosa, PhD · George Washington University Biostatistics Center

• Barbara Linder, MD, PhD · NIDDK Project Scientist

• Kishore Gadde, MD · Pennington Biomedical Research Center

• David Ehrmann, MD · University of Chicago

• Kevin Furlong, MD · Jefferson Medical College of Thomas Jefferson University

• Kathleen Jablonski, PhD · George Washington University Biostatistics Center

• Ronald B Goldberg, MD · University of Miami

• Helen P Hazuda, MD · The University of Texas Health Science Center at San Antonio

• Dana Dabelea, MD, PhD · University of Colorado, Denver

• Medha Munshi, MD · Joslin Diabetes Center

• Steven Kahn, MB, ChB · University of Washington

• Samuel Dagogo-Jack, MD, MB · University of Tennessee

• Mark Molitch, MD · Northwestern University

• Happy Araneta, PhD,MPH · University of California, San Diego

• F. Xavier Pi-Sunyer, MD · Columbia University

• Kieren J Mather, MD · Indiana University

• Michelle Magee, MD · Medstar Health Research Institute

• Karol E Watson, MD · University of California, Los Angeles

• Angela Brown, MD · Washington University School of Medicine

• Sherita Hill Golden, MD, MHS · Johns Hopkins School of Medicine

• David S Schade, MD · The University of New Mexico

• Jill Crandall, MD · Albert Einstein College of Medicine

• Elizabeth Venditti, PhD · University of Pittsburgh

• Marjerie Mau, MD · University of Hawaii

• William Knowler, MD · SW Indian Center, NIDDK

• Santica M Marcovina, PhD · University of Washington

• David M Nathan, MD · Massachusetts General Hospital

• Christine Lee, MD · NIDDK Project Scientist

• Sunder Mudaliar, MD · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-09-30

Primary Completion

2024-10-31

Completion

2025-01-31

FDA Drug

Yes

Countries

• United States

Study Locations