Diabetes Prevention Program Outcomes Study (DPPOS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Diabetes Prevention Program Outcomes Study |
- 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 ]
- 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 |
Participants eligible for inclusion in the DPPOS were those who were enrolled in the Diabetes Prevention Program, a national multi-center controlled clinical trial.
Participation as a volunteer in the DPP.
Contacts and Locations 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 May 21, 2013