NATURAL HISTORY OF THE DEVELOPMENT OF TYPE 1 DIABETES

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。TrialNet联盟的主要目的是开展临床试验，以保护患有1型糖尿病（T1D）或新诊断为T1D的个体的胰腺b细胞。T1D发展的TrialNet自然历史研究的目标是获得有关T1D的自然历史和发病机制的信息，并促进招募和评估可能符合T1D预防试验资格的个体。研究分为三个阶段：每个阶段都需要单独的知情同意书。采用前瞻性队列设计。第一阶段包括筛查与T1D有一级或二级亲属的患者的血液样本中是否存在与T1D相关的生化自身抗体。第二阶段（基线风险评估）包括OGTT、HbA1c、ICA和HLA分型。在某些情况下，还将执行IVGTT。还将获得并保存所有参与者的样本，用于未来的免疫和代谢评估，包括b细胞破坏机制，以及与发生T1D风险相关的遗传研究。在第二阶段完成后，参与者将被划分为五年内发生T1D的三种风险类别之一。第三阶段（随访风险评估）有患1型糖尿病风险的受试者将每隔6个月观察一次，持续5年。在每次就诊时，程序将包括OGTT，自身抗体测试，糖化血红蛋白和血液样本的储存。根据美国糖尿病协会（ADA）的标准，主要研究结果是糖尿病。

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 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 separate 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.