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Trial record 1 of 1 for:    NCT00038727
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Diabetes Prevention Program Outcomes Study (DPPOS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038727
First Posted: June 5, 2002
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Aging (NIA)
National Institute on Minority Health and Health Disparities (NIMHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Center for Research Resources (NCRR)
Office of Research on Women's Health (ORWH)
Centers for Disease Control and Prevention
American Diabetes Association
Indian Health Service
General Clinical Research Program
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
June 4, 2002
June 5, 2002
February 21, 2017
October 24, 2017
October 24, 2017
September 2002
October 2024   (Final data collection date for primary outcome measure)
  • Development of Diabetes. [ Time Frame: 2008 ]
    Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram OGTT, and confirmed with a repeat test).
  • Prevalence of Aggregate Microvascular Complication [ Time Frame: 2012-2013 ]
    Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on eGFR by CKD-Epi (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).
  • Total Cancer Except Non-melanoma Skin Cancer [ Time Frame: 1996-2021 ]
    All primary incident cancers except non-melanoma skin cancer
  • MACE [ Time Frame: 1996-2025 ]
    Defined as MI, stroke and CVD death
Not Provided
Complete list of historical versions of study NCT00038727 on ClinicalTrials.gov Archive Site
  • Microvascular and Cardiovascular Disease Risk Factors [ Time Frame: 2021 ]
    Blood pressure, lipids, medication use, weight, insulin resistance, HbA1c, physical activity by MAQ.
  • Aging Related Outcomes - Cognitive and Physical Function [ Time Frame: 2010 and 2012 ]
    Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ). Physical function assessed with the same two well-validated composite measures : the Short Physical Performance Battery (SPPB) and the Cardiovascular Health Study Frailty criteria. The SPPB is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands. Frailty is classified based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.
  • Subclinical Atherosclerosis [ Time Frame: 2012 ]
    Measured using coronary artery calcification.
  • Quality of Life and Economic Analyses [ Time Frame: 2002-2013 ]
    Quality of life measurements include Beck, SF-36, and QWB.
Not Provided
Not Provided
Not Provided
 
Diabetes Prevention Program Outcomes Study
Diabetes Prevention Program Outcomes Study

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). 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 IFG/IGT 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.

The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: https://dppos.bsc.gwu.edu/web/dppos/dppos
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label phase for metformin
Primary Purpose: Prevention
  • Diabetes Mellitus
  • Cancer
  • CVD
  • Behavioral: DPPOS Group Lifestyle
    Quarterly group lifestyle sessions
  • Drug: Metformin
    Administered as 850mg twice per day, masked in DPP and open label in DPPOS
    Other Name: Glucophage
  • 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
    Other Name: ILS
  • Active Comparator: 1 Original Lifestyle
    randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2
    Interventions:
    • Behavioral: DPPOS Group Lifestyle
    • Behavioral: DPPOS Boost Lifestyle
    • Behavioral: Intensive Lifestyle Group Session
  • Active Comparator: 2 Original Metformin
    randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.
    Interventions:
    • Behavioral: DPPOS Group Lifestyle
    • Drug: Metformin
    • Behavioral: Intensive Lifestyle Group Session
  • Placebo Comparator: 3 Original Placebo
    randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2
    Interventions:
    • Behavioral: DPPOS Group Lifestyle
    • Behavioral: Intensive Lifestyle Group Session

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2779
January 2025
October 2024   (Final data collection date for primary outcome measure)
Participation as a volunteer in the DPP.
Sexes Eligible for Study: All
25 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00038727
IND - DK048489
U01DK048489 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: NIDDK Repository
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Aging (NIA)
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Cancer Institute (NCI)
  • National Eye Institute (NEI)
  • National Center for Research Resources (NCRR)
  • Office of Research on Women's Health (ORWH)
  • Centers for Disease Control and Prevention
  • American Diabetes Association
  • Indian Health Service
  • General Clinical Research Program
  • VA Office of Research and Development
Study Chair: David M. Nathan, MD Massachusetts General Hospital
Principal Investigator: Marinella Temprosa, PhD George Washington University Biostatistics Center
Study Director: Barbara Linder, MD, PhD NIDDK Project Scientist
Principal Investigator: Kishore Gadde, MD Pennington Biomedical Research Center
Principal Investigator: David Ehrmann, MD University of Chicago
Principal Investigator: Kevin Furlong, MD Jefferson Medical College of Thomas Jefferson University
Principal Investigator: Michael Larsen, PhD George Washington University Biostatistics Center
Principal Investigator: Ronald B Goldberg, MD University of Miami
Principal Investigator: Helen P Hazuda, MD The University of Texas Health Science Center at San Antonio
Principal Investigator: Dana Dabelea, MD, PhD University of Colorado, Denver
Principal Investigator: Edward S Horton, MD Joslin Diabetes Center
Principal Investigator: Steven Kahn, MB, ChB University of Washington
Principal Investigator: Samuel Dagogo-Jack, MD, MB University of Tennessee Health Science Center
Principal Investigator: Mark Molitch, MD Northwestern University
Principal Investigator: Elizabeth Barrett-Conner, MD University of California, San Diego
Principal Investigator: F. Xavier Pi-Sunyer, MD St. Luke's-Roosevelt Hospital Center
Principal Investigator: David Marrero, PhD Indiana University
Principal Investigator: Vanita Aroda, MD Medstar Health Research Institute
Principal Investigator: Karol E Watson, MD University of California, Los Angeles
Principal Investigator: Neil White, MD Washington University School of Medicine
Principal Investigator: Sherita Hill Golden, MD, MHS Johns Hopkins School of Medicine
Principal Investigator: David S Schade, MD The University of New Mexico
Principal Investigator: Jill Crandall, MD Albert Einstein College of Medicine, Inc.
Principal Investigator: Elizabeth Venditti, PhD University of Pittsburgh
Principal Investigator: Marjerie Mau, MD University of Hawaii
Principal Investigator: William Knowler, MD SW Indian Center, NIDDK
Principal Investigator: Santica M Marcovina, PhD University of Washington
Principal Investigator: David M Nathan, MD Massachusetts General Hospital
Study Director: Christine Lee, MD NIDDK Project Scientist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP