Diabetes Prevention Program Outcomes Study (DPPOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities
American Diabetes Association
Indian Health Service
General Clinical Research Program
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00038727
First received: June 4, 2002
Last updated: June 16, 2014
Last verified: June 2014

June 4, 2002
June 16, 2014
September 2002
October 2013   (final data collection date for primary outcome measure)
  • development of diabetes. [ Time Frame: 2008 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
Not Provided
Complete list of historical versions of study NCT00038727 on ClinicalTrials.gov Archive Site
  • Microvascular and cardiovascular disease risk factors [ Time Frame: 2013 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured using coronary artery calcification.
  • Quality of life and economic analyses [ Time Frame: 2002-2013 ] [ Designated as safety issue: No ]
    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%.

The DPPOS 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 current DPPOS Executive Summary and protocol, as well as DPP protocol and lifestyle manuals and publications are available at: http://www.bsc.gwu.edu/dpp/index.htmlvdoc

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes Mellitus
  • Behavioral: Group Lifestyle
    Quarterly group lifestyle sessions
  • Drug: Metformin
    Administered as 850mg twice per day
    Other Name: Glucophage
  • Behavioral: Boost Lifestyle
    In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
  • Active Comparator: 1 BLS
    Boost / Lifestyle, previously Intensive Lifestyle during the DPP
    Interventions:
    • Behavioral: Group Lifestyle
    • Behavioral: Boost Lifestyle
  • Active Comparator: 2 MLS
    Metformin / Lifestyle, previously the metformin treatment group during DPP
    Interventions:
    • Behavioral: Group Lifestyle
    • Drug: Metformin
  • Placebo Comparator: 3 GLS
    Group Lifestyle, previously placebo treated participants during DPP
    Intervention: Behavioral: Group Lifestyle

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2776
January 2015
October 2013   (final data collection date for primary outcome measure)

Participation as a volunteer in the DPP.

Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038727
IND - DK048489
Yes
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
  • 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
  • Department of Veterans Affairs
Study Chair: David M. Nathan, MD Massachusetts General Hospital
Principal Investigator: Marinella Temprosa, PhD George Washington University Biostatistics Center
Investigator: Barbara Linder, MD, PhD NIDDK Project Scientist
Principal Investigator: George A Bray, 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 Research Institute
Principal Investigator: Karol E Watson, MD University of California, Los Angeles
Principal Investigator: Neil White, MD Washington University Early Recognition Center
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 of Yeshiva University
Principal Investigator: Trevor J Orchard, MD University of Pittsburgh
Principal Investigator: Richard Arakaki, 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
June 2014

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