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Diabetes Prevention Program Outcomes Study (DPPOS)

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ClinicalTrials.gov Identifier: NCT00038727
Recruitment Status : Active, not recruiting
First Posted : June 5, 2002
Results First Posted : October 24, 2017
Last Update Posted : August 8, 2019
Sponsor:
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
US Department of Veterans Affairs
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE June 4, 2002
First Posted Date  ICMJE June 5, 2002
Results First Submitted Date  ICMJE February 21, 2017
Results First Posted Date  ICMJE October 24, 2017
Last Update Posted Date August 8, 2019
Study Start Date  ICMJE September 2002
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • Development of Diabetes. [ Time Frame: Data from 2008 provides an average of 10 years of follow-up after randomization ]
    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 oral glucose tolerance test (OGTT), and confirmed with a repeat test).
  • Prevalence of Aggregate Microvascular Complication [ Time Frame: The years 2012-2013 reflect an average of 15 years of follow-up post randomization. ]
    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 estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).
  • Total Cancer Except Non-melanoma Skin Cancer [ Time Frame: The event driven analysis will be conducted when there are 199 adjudicated placebo events expected before 2020 which will provide an average follow-up of 23 years since randomization. ]
    All primary incident cancers except non-melanoma skin cancer
  • Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) [ Time Frame: Year 2025 data reflects an average of 27 years of average follow-up. ]
    Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00038727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Subclinical Atherosclerosis [ Time Frame: The year 2012 provides an average of 14 years of average follow-up. ]
    Measured using coronary artery calcification (CAC).
  • Cognitive Function [ Time Frame: The measures were initiated between 2010-2020 during visits ending in years 2010, 2012, 2017, 2020. ]
    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 ).
  • Short Physical Performance Battery [ Time Frame: The measures were initiated between 2010-2020 during visits ending in years 2010, 2012, 2017, 2020. ]
    Physical function is measured using the short physical performance battery (SPPB), which 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 [ Time Frame: The measures were initiated between 2010-2020 during visits ending in years 2010, 2012, 2017, 2020. ]
    Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetes Prevention Program Outcomes Study
Official Title  ICMJE Diabetes Prevention Program Outcomes Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label phase for metformin
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus
  • Cancer
  • CVD
Intervention  ICMJE
  • 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: Intensive lifestyle session (ILS)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 25, 2017)
2779
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
3819
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Participation as a volunteer in the Diabetes Prevention Program (DPP).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00038727
Other Study ID Numbers  ICMJE IND - DK048489
U01DK048489 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository
Time Frame: 2002-2025
Access Criteria: Instructions for access are detailed here: https://repository.niddk.nih.gov/pages/overall_instructions/
URL: https://repository.niddk.nih.gov/studies/dppos/
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE
  • 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
  • US Department of Veterans Affairs
Investigators  ICMJE
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: Kathleen Jablonski, 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: Medha Munshi, 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: Happy Araneta, PhD,MPH University of California, San Diego
Principal Investigator: F. Xavier Pi-Sunyer, MD Columbia University
Principal Investigator: Kieren J Mather, MD Indiana University
Principal Investigator: Michelle Magee, MD Medstar Health Research Institute
Principal Investigator: Karol E Watson, MD University of California, Los Angeles
Principal Investigator: Angela Brown, 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
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
Principal Investigator: Sunder Mudaliar, MD University of California, San Diego
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date July 2019

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