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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Indian Health Service
General Clinical Research Program
American Diabetes Association
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00038727
First received: June 4, 2002
Last updated: September 19, 2011
Last verified: September 2011
  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 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetes Prevention Program Outcomes Study

Resource links provided by NLM:


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

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
Indian Health Service
General Clinical Research Program
American Diabetes Association
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

Responsible Party: Sandy Garfield, PhD, Senior Advisor for Biometry and Behavioral Research, NIDDK
ClinicalTrials.gov Identifier: NCT00038727     History of Changes
Obsolete Identifiers: NCT00353314
Other Study ID Numbers: IND - DK048489
Study First Received: June 4, 2002
Last Updated: September 19, 2011
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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014