Diabetes Prevention Program Outcomes Study
This trial is active, not recruiting.
|Treatments||group lifestyle, metformin, boost lifestyle|
|Sponsor||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborator||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Start date||September 2002|
|End date||October 2013|
|Trial size||2776 participants|
|Trial identifier||NCT00038727, IND - DK048489, NCT00353314|
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 IFG/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 microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
development of diabetes.
time frame: 2008
Prevalence of aggregate microvascular complication
time frame: 2012-2013
Microvascular and cardiovascular disease risk factors
time frame: 2013
Aging related outcomes - Cognitive and Physical Function
time frame: 2010 and 2012
time frame: 2012
Quality of life and economic analyses
time frame: 2002-2013
Male or female participants at least 25 years old.
Participation as a volunteer in the DPP.
|Official title||Diabetes Prevention Program Outcomes Study|
|Principal investigator||Marinella Temprosa, PhD|
|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|
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