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Spots Global Cancer Trial Database for Diabetes Prevention Program Outcomes Study

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Trial Identification

Brief Title: Diabetes Prevention Program Outcomes Study

Official Title: Diabetes Prevention Program Outcomes Study

Study ID: NCT00038727

Study Description

Brief 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

Eligibility

Minimum Age: 25 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

George Washington University, Rockville, Maryland, United States

Contact Details

Name: David M. Nathan, MD

Affiliation: Massachusetts General Hospital

Role: STUDY_CHAIR

Name: Marinella Temprosa, PhD

Affiliation: George Washington University Biostatistics Center

Role: PRINCIPAL_INVESTIGATOR

Name: Barbara Linder, MD, PhD

Affiliation: NIDDK Project Scientist

Role: STUDY_DIRECTOR

Name: Kishore Gadde, MD

Affiliation: Pennington Biomedical Research Center

Role: PRINCIPAL_INVESTIGATOR

Name: David Ehrmann, MD

Affiliation: University of Chicago

Role: PRINCIPAL_INVESTIGATOR

Name: Kevin Furlong, MD

Affiliation: Jefferson Medical College of Thomas Jefferson University

Role: PRINCIPAL_INVESTIGATOR

Name: Kathleen Jablonski, PhD

Affiliation: George Washington University Biostatistics Center

Role: PRINCIPAL_INVESTIGATOR

Name: Ronald B Goldberg, MD

Affiliation: University of Miami

Role: PRINCIPAL_INVESTIGATOR

Name: Helen P Hazuda, MD

Affiliation: The University of Texas Health Science Center at San Antonio

Role: PRINCIPAL_INVESTIGATOR

Name: Dana Dabelea, MD, PhD

Affiliation: University of Colorado, Denver

Role: PRINCIPAL_INVESTIGATOR

Name: Medha Munshi, MD

Affiliation: Joslin Diabetes Center

Role: PRINCIPAL_INVESTIGATOR

Name: Steven Kahn, MB, ChB

Affiliation: University of Washington

Role: PRINCIPAL_INVESTIGATOR

Name: Samuel Dagogo-Jack, MD, MB

Affiliation: University of Tennessee

Role: PRINCIPAL_INVESTIGATOR

Name: Mark Molitch, MD

Affiliation: Northwestern University

Role: PRINCIPAL_INVESTIGATOR

Name: Happy Araneta, PhD,MPH

Affiliation: University of California, San Diego

Role: PRINCIPAL_INVESTIGATOR

Name: F. Xavier Pi-Sunyer, MD

Affiliation: Columbia University

Role: PRINCIPAL_INVESTIGATOR

Name: Kieren J Mather, MD

Affiliation: Indiana University

Role: PRINCIPAL_INVESTIGATOR

Name: Michelle Magee, MD

Affiliation: Medstar Health Research Institute

Role: PRINCIPAL_INVESTIGATOR

Name: Karol E Watson, MD

Affiliation: University of California, Los Angeles

Role: PRINCIPAL_INVESTIGATOR

Name: Angela Brown, MD

Affiliation: Washington University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Sherita Hill Golden, MD, MHS

Affiliation: Johns Hopkins School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: David S Schade, MD

Affiliation: The University of New Mexico

Role: PRINCIPAL_INVESTIGATOR

Name: Jill Crandall, MD

Affiliation: Albert Einstein College of Medicine

Role: PRINCIPAL_INVESTIGATOR

Name: Elizabeth Venditti, PhD

Affiliation: University of Pittsburgh

Role: PRINCIPAL_INVESTIGATOR

Name: Marjerie Mau, MD

Affiliation: University of Hawaii

Role: PRINCIPAL_INVESTIGATOR

Name: William Knowler, MD

Affiliation: SW Indian Center, NIDDK

Role: PRINCIPAL_INVESTIGATOR

Name: Santica M Marcovina, PhD

Affiliation: University of Washington

Role: PRINCIPAL_INVESTIGATOR

Name: David M Nathan, MD

Affiliation: Massachusetts General Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Christine Lee, MD

Affiliation: NIDDK Project Scientist

Role: STUDY_DIRECTOR

Name: Sunder Mudaliar, MD

Affiliation: University of California, San Diego

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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