NATURAL HISTORY OF THE DEVELOPMENT OF TYPE 1 DIABETES

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 TrialNet联盟的主要目的是开发保护1型糖尿病（T1 D）风险或新诊断为T1 D的个体的胰腺B细胞的治疗的临床试验。 TrialNet T1 D发展自然史研究的目标是获得有关T1 D自然史和发病机制的信息，并促进招募和评估可能有资格参加T1 D预防试验的个人。 研究分为三个阶段：每个阶段都需要单独的知情同意书才能进入。 将采用前瞻性队列设计。 第一阶段包括筛查血液样本中与T1 D相关的生化自身抗体的存在，这些抗体存在于与T1 D有一级或二级亲属的人中。 第2阶段（基线风险评估）包括OGTT、HbA 1c、伊卡和HLA分型。 在某些情况下，还将进行IVGTT。 还将从所有参与者中获取并储存样本，用于未来的免疫和代谢评估，这些评估将承担B细胞破坏机制，以及与发展T1 D风险相关的遗传研究。 在第二阶段完成后，参与者将在五年内被归类为T1 D发生的三个风险类别之一。 3期（随访风险评估）将每6个月观察一次有1型糖尿病风险的受试者，持续5年。 每次访视时，程序将包括OGTT、自身抗体检测、HbA 1c和血液样本储存。 主要研究结果是根据美国糖尿病协会（ADA）标准的糖尿病。

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 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.