This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The major purpose of the TrialNet consortium is to develop clinical trials of treatments that protect pancreatic B-cells in individuals who are at risk for developing type 1 diabetes (T1D) or who have newly diagnosed T1D. The goals of the TrialNet Natural History Study of the Development of T1D are to gain information about the natural history and pathogenesis of T1D and to facilitate the recruitment and assessment of individuals who might qualify for T1D prevention trials.The study is divided into three phases: Each of these phases will require seperate informed consent for entry. A prospective cohort design will be used.Phase 1 involves screening blood samples for the presence of biochemical autoantibodies associated with T1D in persons with a first or second-degree relative with T1D.Phase 2 (Baseline Risk Assessment) includes an OGTT, HbA1c, ICA, and HLA typing. In certain cases, IVGTT will also be performed. Samples will also be obtained and stored from all participants for future immunologic and metabolic assessments that bear mechanisms of B-cell destruction, and genetic studies related to the risk of developing T1D. Upon completion of Phase 2, participants will be classified onto one of the three risk categories for the occurrence of T1D within five years.Phase 3 (Follow-Up Risk Assessments) subjects at risk for developing type-1 diabetes will be seen at six-month intervals for five years. At each visit, procedures will include an OGTT, autoantibody testing, HbA1c and blood sample for storage.The primary study outcome is diabetes mellitus by the American Diabetes Association (ADA) criteria.
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