TRIALNET HISTORY STUDY OF THE DEVELOPMENT OF TYPE I DIABETES

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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. This study will evaluate and follow first and second degree relatives of persons with type 1 diabetes mellitus (T1DM) to characterize their risk of developing T1DM, to study the natural history of progression to T1DM among antibody-positive relatives, and to identify subjects at risk for T1DM for participation in clinical trials related to the prevention of T1DM. This study is divided into three phases. During Phase 1 (screening), subjects will have a single blood sample for determination of islet cell antibodies and a second sample to confirm antibodies if the first sample was positive. During Phase 2 (baseline assessment), islet cell antibody positive subjects will have a risk assessment done including confirmation of islet cell antibody status (if necessary), HLA typing, oral glucose tolerance test (OGTT), hemoglobin A1c (HbA1c) and in some cases an intravenous glucose tolerance test (IVGTT). During Phase 3 (follow-up assessments), participants will have determination of antibodies, and HbA1c and an OGTT every 6 months to determine if they have developed diabetes and to follow the natural history of progression to diabetes. Former participants in the Diabetes Prevention Trial-Type 1 Diabetes (DPT-1; now closed) will be enrolled directly into Phase 3 since they have already been demonstrated to be at higher risk for T1DM during their participation in DPT-1. Subjects participating in Phase 3 of this protocol who are eligible for participation in a TrialNet diabetes prevention trial (not described herein) may be withdrawn from this study.