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Brief Title: Diabetes Prevention Program Outcomes Study
Official Title: Diabetes Prevention Program Outcomes Study
Study ID: NCT00038727
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
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
George Washington University, Rockville, Maryland, United States
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