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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:
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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Group Lifestyle
Drug: Metformin
Behavioral: Boost Lifestyle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diabetes Prevention Program Outcomes Study

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 2776
Study Start Date: September 2002
Estimated Study Completion Date: January 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 BLS
Boost / Lifestyle, previously Intensive Lifestyle during the DPP
Behavioral: Group Lifestyle
Quarterly group lifestyle sessions
Behavioral: Boost Lifestyle
In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
Active Comparator: 2 MLS
Metformin / Lifestyle, previously the metformin treatment group during DPP
Behavioral: Group Lifestyle
Quarterly group lifestyle sessions
Drug: Metformin
Administered as 850mg twice per day
Other Name: Glucophage
Placebo Comparator: 3 GLS
Group Lifestyle, previously placebo treated participants during DPP
Behavioral: Group Lifestyle
Quarterly group lifestyle sessions

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Participation as a volunteer in the DPP.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038727

Locations
United States, Maryland
George Washington University
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
National Institute on Minority Health and Health Disparities
American Diabetes Association
Indian Health Service
General Clinical Research Program
Investigators
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 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 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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00038727     History of Changes
Obsolete Identifiers: NCT00353314
Other Study ID Numbers: IND - DK048489
Study First Received: June 4, 2002
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
DPP
IGT
Prediabetes
Type 2 diabetes
Macrovascular disease
Microvascular disease

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014