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

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.
 
ClinicalTrials.gov Identifier: NCT00038727
Recruitment Status : Active, not recruiting
First Posted : June 5, 2002
Results First Posted : October 24, 2017
Last Update Posted : December 28, 2021
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)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Cancer CVD Behavioral: DPPOS Group Lifestyle Drug: Metformin Behavioral: DPPOS Boost Lifestyle Behavioral: Intensive Lifestyle Group Session Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2779 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label phase for metformin
Primary Purpose: Prevention
Official Title: Diabetes Prevention Program Outcomes Study
Study Start Date : September 2002
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Behavioral: DPPOS Group Lifestyle
Quarterly group lifestyle sessions

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)
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.
 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: Intensive Lifestyle Group Session
16 session curriculum in group format. In DPP delivered to ILS as individual sessions
Other Name: Intensive lifestyle session (ILS)
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
 Behavioral: DPPOS Group Lifestyle
Quarterly group lifestyle sessions

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)


Outcome Measures
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Primary Outcome Measures :
  1. Development of Diabetes. [ Time Frame: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP). ]
    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).

  2. Prevalence of Aggregate Microvascular Complication [ Time Frame: Outcomes were assessed from 2012-2013 (approximately 2 years). ]
    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).

  3. Total Cancer Except Non-melanoma Skin Cancer [ Time Frame: Outcomes were assessed from 1996-2020 (approximately 24 years). ]
    All primary incident cancers except non-melanoma skin cancer

  4. Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) [ Time Frame: Outcomes were assessed from 1996-2025 (approximately 29 years). ]
    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.


Secondary Outcome Measures :
  1. Subclinical Atherosclerosis [ Time Frame: Outcomes were assessed from 2012-2013 (approximately 2 years). ]
    Measured using coronary artery calcification (CAC).

  2. Cognitive Function [ Time Frame: Outcomes were assessed in visit years starting in 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 ).

  3. Short Physical Performance Battery [ Time Frame: Outcomes were assessed in visit years starting in 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.

  4. Frailty [ Time Frame: Outcomes were assessed in visit years starting in 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.

  5. Mortality [ Time Frame: 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. ]
    All cause-mortality through clinic reports and National Death Index search


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Participation as a volunteer in the Diabetes Prevention Program (DPP).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038727


Locations
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United States, Maryland
George Washington University
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
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
US Department of Veterans Affairs
Investigators
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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
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
  Study Documents (Full-Text)

Documents provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Study Protocol and Statistical Analysis Plan  [PDF] May 22, 2019
Informed Consent Form  [PDF] November 27, 2017

More Information
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Additional Information:

Publications of Results:

Other Publications:

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

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00038727    
Obsolete Identifiers: NCT00353314
Other Study ID Numbers: DPPOS
U01DK048489 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2002    Key Record Dates
Results First Posted: October 24, 2017
Last Update Posted: December 28, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
DPP
IGT
Prediabetes
Type 2 diabetes
Macrovascular disease
 Microvascular disease
Lifestyle
Metformin
Obesity
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs