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

June 4, 2002
September 19, 2011
September 2002
Not Provided
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 ]
Not Provided
Complete list of historical versions of study NCT00038727 on ClinicalTrials.gov Archive Site
  • 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 ]
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Diabetes Prevention Program Outcomes Study
Diabetes Prevention Program Outcomes Study

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
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

Non-Probability Sample

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

Diabetes Mellitus
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3250
Not Provided
Not Provided

Participation as a volunteer in the DPP.

Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038727
IND - DK048489
Yes
Sandy Garfield, PhD, Senior Advisor for Biometry and Behavioral Research, NIDDK
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 Center on Minority Health and Health Disparities (NCMHD)
  • Office of Research on Women's Health (ORWH)
  • Indian Health Service
  • Centers for Disease Control and Prevention
  • General Clinical Research Program
  • National Center for Research Resources (NCRR)
  • American Diabetes Association
  • National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP