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Diabetes Prevention Program Outcomes Study (DPPOS)

Primary Purpose

Diabetes Mellitus, Cancer, CVD

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DPPOS Group Lifestyle
Metformin
DPPOS Boost Lifestyle
Intensive Lifestyle Group Session
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring DPP, IGT, Prediabetes, Type 2 diabetes, Macrovascular disease, Microvascular disease, Lifestyle, Metformin, Obesity

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • George Washington University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1 Original Lifestyle

2 Original Metformin

3 Original Placebo

Arm Description

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

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.

randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2

Outcomes

Primary Outcome Measures

Development of Diabetes.
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
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
All primary incident cancers except non-melanoma skin cancer
Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
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

Subclinical Atherosclerosis
Measured using coronary artery calcification (CAC).
Cognitive Function
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
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
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.
Mortality
All cause-mortality through clinic reports and National Death Index search

Full Information

First Posted
June 4, 2002
Last Updated
December 3, 2021
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
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1. Study Identification

Unique Protocol Identification Number
NCT00038727
Brief Title
Diabetes Prevention Program Outcomes Study
Acronym
DPPOS
Official Title
Diabetes Prevention Program Outcomes Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2002 (undefined)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Cancer, CVD
Keywords
DPP, IGT, Prediabetes, Type 2 diabetes, Macrovascular disease, Microvascular disease, Lifestyle, Metformin, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label phase for metformin
Allocation
Randomized
Enrollment
2779 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Original Lifestyle
Arm Type
Active Comparator
Arm Description
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
Arm Title
2 Original Metformin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3 Original Placebo
Arm Type
Placebo Comparator
Arm Description
randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2
Intervention Type
Behavioral
Intervention Name(s)
DPPOS Group Lifestyle
Intervention Description
Quarterly group lifestyle sessions
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
Administered as 850mg twice per day, masked in DPP and open label in DPPOS
Intervention Type
Behavioral
Intervention Name(s)
DPPOS Boost Lifestyle
Intervention Description
In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle Group Session
Other Intervention Name(s)
Intensive lifestyle session (ILS)
Intervention Description
16 session curriculum in group format. In DPP delivered to ILS as individual sessions
Primary Outcome Measure Information:
Title
Development of Diabetes.
Description
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).
Time Frame
Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
Title
Prevalence of Aggregate Microvascular Complication
Description
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).
Time Frame
Outcomes were assessed from 2012-2013 (approximately 2 years).
Title
Total Cancer Except Non-melanoma Skin Cancer
Description
All primary incident cancers except non-melanoma skin cancer
Time Frame
Outcomes were assessed from 1996-2020 (approximately 24 years).
Title
Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)
Description
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.
Time Frame
Outcomes were assessed from 1996-2025 (approximately 29 years).
Secondary Outcome Measure Information:
Title
Subclinical Atherosclerosis
Description
Measured using coronary artery calcification (CAC).
Time Frame
Outcomes were assessed from 2012-2013 (approximately 2 years).
Title
Cognitive Function
Description
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 ).
Time Frame
Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
Title
Short Physical Performance Battery
Description
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.
Time Frame
Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
Title
Frailty
Description
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.
Time Frame
Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
Title
Mortality
Description
All cause-mortality through clinic reports and National Death Index search
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participation as a volunteer in the Diabetes Prevention Program (DPP).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Nathan, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marinella Temprosa, PhD
Organizational Affiliation
George Washington University Biostatistics Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Linder, MD, PhD
Organizational Affiliation
NIDDK Project Scientist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kishore Gadde, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Ehrmann, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Furlong, MD
Organizational Affiliation
Jefferson Medical College of Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen Jablonski, PhD
Organizational Affiliation
George Washington University Biostatistics Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald B Goldberg, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen P Hazuda, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana Dabelea, MD, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Medha Munshi, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Kahn, MB, ChB
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Dagogo-Jack, MD, MB
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Molitch, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Happy Araneta, PhD,MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
F. Xavier Pi-Sunyer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kieren J Mather, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Magee, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karol E Watson, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Brown, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherita Hill Golden, MD, MHS
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David S Schade, MD
Organizational Affiliation
The University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill Crandall, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Venditti, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjerie Mau, MD
Organizational Affiliation
University of Hawaii
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Knowler, MD
Organizational Affiliation
SW Indian Center, NIDDK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Santica M Marcovina, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David M Nathan, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Lee, MD
Organizational Affiliation
NIDDK Project Scientist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sunder Mudaliar, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing URL
https://repository.niddk.nih.gov/studies/dppos/
Citations:
PubMed Identifier
11832527
Citation
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Citation
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Diabetes Prevention Program Research Group. HbA1c as a predictor of diabetes and as an outcome in the diabetes prevention program: a randomized clinical trial. Diabetes Care. 2015 Jan;38(1):51-8. doi: 10.2337/dc14-0886. Epub 2014 Oct 21.
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Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE; Diabetes Prevention Program Research Group. Effect of regression from prediabetes to normal glucose regulation on long-term reduction in diabetes risk: results from the Diabetes Prevention Program Outcomes Study. Lancet. 2012 Jun 16;379(9833):2243-51. doi: 10.1016/S0140-6736(12)60525-X. Epub 2012 Jun 9.
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Diabetes Prevention Program Research Group. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2012 Apr;35(4):731-7. doi: 10.2337/dc11-1299.
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Links:
URL
http://www.dppos.org
Description
Study website
URL
http://clinicaltrials.gov/ct2/show/NCT00004992
Description
Clinical trials.gov entry for DPP

Learn more about this trial

Diabetes Prevention Program Outcomes Study

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