This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The design of TrialNet protocol is similar to the study implemented at TCH as a part of the national Diabetes Prevention Trial-Type 1 (DPT-1). Visits scheduled on the GCRC will begin at either Phase 2 or Phase 3 for eligible subjects. Phase 1 involves screening of relatives of people with type 1 diabetes for biochemical islet cell antibodies in the outpatient setting of the Barbara Davis Center. All laboratory evaluations for the TrialNet Natural History study will be measured by laboratories outside of TCH. If only one autoantibody is present, a second sample will be drawn by the Barbara Davis Center staff and submitted for confirmation of the positive autoantibody. If confirmed, the individual will be eligible for Phase 2 of the protocol which includes the performance of an oral glucose tolerance test (OGTT) at TCH on the GCRC. A few of these participants may require an intravenous glucose tolerance test (IVGTT) in order to assess their risk for developing type 1 diabetes. This test will also be done on the GCRC. For individuals who have two or more islet cell autoantibodies in their initial blood sample evaluation, the confirmation sample can be drawn in Phase 2 which, as noted above, includes the performance of an OGTT. Individuals who had metabolic testing while participants in DPT-1 will be eligible for entry into the TrialNet Natural History Study at Phase 3 which includes the performance of an OGTT at 6-month intervals. A select group (randomly chosen) of autoantibody negative participants will be eligible for entry into the TrialNet Natural History Study at Phase 3. The metabolic testing (OGTT only) for this group will be performed annually on the GCRC. Other protocols within TrialNet which might need to use the services of the GCRC, will be submitted on an individual basis to both the GCRC and COMIRB separately from this 'Natural History Study'.
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