Diabetes Prevention Program Outcomes Study - Full Text View

Diabetes Prevention Program Outcomes Study (DPPOS)

This study is ongoing, but not recruiting participants.

First Received: June 4, 2002 Last Updated: July 31, 2008 History of Changes

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) The Office of Research on Minority Health and Health Disparities Office of Women’s Health Indian Health Service Centers for Disease Control and Prevention General Clinical Research Program National Center for Research Resources (NCRR) American Diabetes Association
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00038727

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 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 CVD, CVD risk factors and atherosclerosis and microvascular disease, 3)close examination of these topics in men vs women and in minority populations.

Condition	Phase
Diabetes Mellitus	Phase III

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Diabetes Prevention Program Outcomes Study

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

Primary Outcome Measures:

development of diabetes 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). [ Time Frame: 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite Microvascular: Including having one or more of: a) a score > 2 on the Michigan Neuropathy Screening Index (MNSI), b) the development of albuminuria or renal dysfunction ,or c) retinopathy by fundus photography. [ Time Frame: 2013 ] [ Designated as safety issue: No ]
Composite Macrovascular: Including one or more: a) cardiovascular disease b) silent MI c) coronary artery stenosis or d) clinically relevant carotid ultrasound measured intimal-medial thickness or f) an ankle: brachial blood pressure ratio < 0.9. [ Time Frame: 2013 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

DPPOS participants have blood samples stored at the time of each annual visit. Specimens are stored at the study CBL until after the primary study outcomes are reported. DNA samples were previously collected and are stored at the NIDDK sample repository for DPP participants

Enrollment:	3250
Study Start Date:	September 2002

Groups/Cohorts
1 BLS Boost / Lifestyle, previously Intensive Lifestyle during the DPP
2 MLS Metformin / Lifestyle, previously the metformin treatment group during DPP
3 GLS Group Lifestyle, previously placebo and troglitazone treated participants during DPP

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
Sampling Method:	Non-Probability Sample

Study Population

Participants eligible for inclusion in the DPPOS were those who were enrolled in the Diabetes Prevention Program, a national multi-center controlled clinical trial.

Criteria

Participation as a volunteer in the DPP.

Contacts and Locations

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 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)

The Office of Research on Minority Health and Health Disparities

Office of Women’s Health

Indian Health Service

Centers for Disease Control and Prevention

General Clinical Research Program

National Center for Research Resources (NCRR)

American Diabetes Association

More Information

No publications provided

Responsible Party:	NIDDK ( Sandy Garfield, PhD, Senior Advisor for Biometry and Behavioral Research )
Study ID Numbers:	DK048489
Study First Received:	June 4, 2002
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00038727 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

DPP
IGT
Type 2 diabetes
Macrovascular disease
Microvascular disease

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009