Diabetes Prevention Program Outcomes Study - Tabular View

Tracking Information
First Received Date ^ICMJE	June 4, 2002
Last Updated Date	July 31, 2008
Start Date ^ICMJE	September 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: July 31, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00038727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 31, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Diabetes Prevention Program Outcomes Study
Official Title ^ICMJE	Diabetes Prevention Program Outcomes Study
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). 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.
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
Study Phase	Phase III
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Cohort, Prospective
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE
Study Arms / Comparison Groups	Boost / Lifestyle, previously Intensive Lifestyle during the DPP Metformin / Lifestyle, previously the metformin treatment group during DPP Group Lifestyle, previously placebo and troglitazone treated participants during DPP
Publications *	Crandall JP, Polsky S, Howard AA, Perreault L, Bray GA, Barrett-Connor E, Brown-Friday J, Whittington T, Foo S, Ma Y, Edelstein SL; Diabetes Prevention Program Research Group. Alcohol consumption and diabetes risk in the Diabetes Prevention Program. Am J Clin Nutr. 2009 Sep;90(3):595-601. Epub 2009 Jul 29.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	3250
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Participation as a volunteer in the DPP.
Gender	Both
Ages	25 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038727
Responsible Party	Sandy Garfield, PhD, Senior Advisor for Biometry and Behavioral Research, NIDDK
Study ID Numbers ^ICMJE	DK048489
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE	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
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP