Clinical trial NCT00038727: Diabetes Prevention Program Outcomes Study
Official title: Diabetes Prevention Program Outcomes Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus
Cancer
CVD
Keywords: DPP
IGT
Prediabetes
Type 2 diabetes
Macrovascular disease
Microvascular disease
Lifestyle
Metformin
Obesity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Aging (NIA)
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Cancer Institute (NCI)
name: National Eye Institute (NEI)
name: National Center for Research Resources (NCRR)
name: Office of Research on Women's Health (ORWH)
name: Centers for Disease Control and Prevention
name: American Diabetes Association
name: Indian Health Service (IHS)
name: General Clinical Research Program
name: US Department of Veterans Affairs
First posted: 2002-06-05
Enrollment: 2779
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 criteria: Participation as a volunteer in the Diabetes Prevention Program (DPP).

Primary outcomes:
measure: Development of Diabetes.
timeFrame: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
measure: Prevalence of Aggregate Microvascular Complication
timeFrame: Outcomes were assessed from 2012-2013 (approximately 2 years).
measure: Total Cancer Except Non-melanoma Skin Cancer
timeFrame: Outcomes were assessed from 1996-2020 (approximately 24 years).
measure: Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
timeFrame: Outcomes were assessed from 1996-2025 (approximately 29 years).
Secondary outcomes:
measure: Subclinical Atherosclerosis
timeFrame: Outcomes were assessed from 2012-2013 (approximately 2 years).
measure: Cognitive Function
timeFrame: Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
measure: Short Physical Performance Battery
timeFrame: Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
measure: Frailty
timeFrame: Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
measure: Mortality
timeFrame: Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.
Other outcomes:
Locations:
city: Rockville
country: United States
facility: George Washington University
state: Maryland
Study officials:
affiliation: Massachusetts General Hospital
name: David M. Nathan, MD
role: STUDY_CHAIR
affiliation: George Washington University Biostatistics Center
name: Marinella Temprosa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NIDDK Project Scientist
name: Barbara Linder, MD, PhD
role: STUDY_DIRECTOR
affiliation: Pennington Biomedical Research Center
name: Kishore Gadde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: David Ehrmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jefferson Medical College of Thomas Jefferson University
name: Kevin Furlong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University Biostatistics Center
name: Kathleen Jablonski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Ronald B Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Helen P Hazuda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Dana Dabelea, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Joslin Diabetes Center
name: Medha Munshi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Steven Kahn, MB, ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Samuel Dagogo-Jack, MD, MB
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Mark Molitch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Happy Araneta, PhD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: F. Xavier Pi-Sunyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Kieren J Mather, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Michelle Magee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Karol E Watson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Angela Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Sherita Hill Golden, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of New Mexico
name: David S Schade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Jill Crandall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Elizabeth Venditti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii
name: Marjerie Mau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SW Indian Center, NIDDK
name: William Knowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Santica M Marcovina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: David M Nathan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NIDDK Project Scientist
name: Christine Lee, MD
role: STUDY_DIRECTOR
affiliation: University of California, San Diego
name: Sunder Mudaliar, MD
role: PRINCIPAL_INVESTIGATOR
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