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Type 1 Diabetes TrialNet: Clinical Centers (U01): (RFA-DK-08-011)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases

National Center for Complementary and Alternative Medicine

National Institute of Allergy and Infectious Diseases

Eunice Kennedy Shriver National Institute of Child Health and Human Development

Application Receipt Date(s): March 10, 2009

Earliest Anticipated Start Date: September, 2009

Expiration Date: March 11, 2009

This FOA is being issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Center for Complementary and Alternative Medicine (NCCAM) to solicit applications to support clinical centers which will participate in studies aimed at preventing or delaying the onset or progression of type 1 diabetes (T1D) as part of the TrialNet clinical research network. TrialNet is working to achieve its goals through improving understanding of the natural history of the disease, screening and identifying persons at risk, and conducting clinical trials to evaluate promising new therapies that interdict the disease process. Most importantly, TrialNet evaluates new therapies, especially immunotherapies, in individuals (including children) who do not yet have clinical disease. To support the goal of prevention, TrialNet also performs studies that generate safety and efficacy information in individuals with newly-diagnosed diabetes. TrialNet tests interventions in patients with recent onset T1D to decrease b-cell destruction and/or enhance b-cell survival or regeneration in persons with T1D and residual b-cell function. In addition, TrialNet also evaluates methodologies to enhance the conduct of its clinical trials, which include tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies (studies to understand underlying pathophysiology) laying the foundation for future clinical trials.

This Funding Opportunity Announcement (FOA) will utilize the cooperative agreement (U01) grant mechanism. The NIDDK intends to …

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