Diabetes Prevention Program Outcomes Study (DPPOS)

December 3, 2021 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

2779

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20852
        • George Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Participation as a volunteer in the Diabetes Prevention Program (DPP).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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
Behavioral: Intensive Lifestyle Group Session
16 session curriculum in group format. In DPP delivered to ILS as individual sessions
Other Names:
  • Intensive lifestyle session (ILS)
Drug: Metformin
Administered as 850mg twice per day, masked in DPP and open label in DPPOS
Other Names:
  • Glucophage
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 Names:
  • Intensive lifestyle session (ILS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
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).
Outcomes were assessed from 2012-2013 (approximately 2 years).
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
Outcomes were assessed from 1996-2020 (approximately 24 years).
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.
Outcomes were assessed from 1996-2025 (approximately 29 years).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subclinical Atherosclerosis
Time Frame: Outcomes were assessed from 2012-2013 (approximately 2 years).
Measured using coronary artery calcification (CAC).
Outcomes were assessed from 2012-2013 (approximately 2 years).
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 ).
Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
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.
Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
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.
Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

National Cancer Institute (NCI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
National Eye Institute (NEI)
National Institute on Aging (NIA)
US Department of Veterans Affairs
Centers for Disease Control and Prevention
National Center for Research Resources (NCRR)
American Diabetes Association
Office of Research on Women's Health (ORWH)
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
  • 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: 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
  • Study Director: Christine Lee, MD, NIDDK Project Scientist
  • Principal Investigator: Sunder Mudaliar, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

June 4, 2002

First Submitted That Met QC Criteria

June 4, 2002

First Posted (Estimate)

June 5, 2002

Study Record Updates

Last Update Posted (Actual)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPPOS
  • U01DK048489 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository

IPD Sharing Time Frame

2002-2025

IPD Sharing Access Criteria

Instructions for access are detailed here: https://repository.niddk.nih.gov/pages/overall_instructions/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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