NATURAL HISTORY STUDY OF THE DEVELOPMENT OF TYPE 1 DIABETES TYPE 1 TRIALNET PROT

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。 NIH资助的TrialNet T1 D发展自然史研究的目标是获得有关T1 D发病机制和自然史的信息，并促进招募和评估可能有资格参加T1 D预防试验的个人。 T1 D发展的TrialNet自然史研究分为三个阶段：筛选（第1阶段），基线风险评估（第2阶段）和随访风险评估（第3阶段）。 第1阶段包括筛查与T1 D相关的自身抗体的存在。 筛选期间两份单独血液样本中单一生化自身抗体阳性的个体将有资格进入研究的II期。 获得的第一份血液样本中至少两种生化自身抗体阳性的个体将有资格进入II期。 基线风险评估将包括口服葡萄糖耐量试验（OGTT）、HbA 1c、伊卡和HLA分型。 还可以进行20分钟静脉葡萄糖耐量试验（IVGTT），以检测第一时相胰岛素反应（FPIR）。 在第二阶段完成后，参与者将被分为三个风险类别之一，在五年内发生T1 D。 完成第2阶段的个人将有资格进入第3阶段，他们将在五年内每六个月接受一次检查。 根据美国糖尿病协会标准，主要研究结局为T1 D。

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 goals of the NIH-funded TrialNet Natural History Study of the Development of T1D are to both gain information about the pathogenesis and natural history of T1D and to facilitate the recruitment and assessment of individuals who might qualify for T1D prevention trials. The TrialNet Natural History Study of the Development of T1D is divided into three phases: Screening (Phase 1), Baseline Risk Assessment (Phase 2) and Follow-up Risk Assessments (Phase 3). Phase 1 involves screening for the presence of autoantibodies associated with T1D. Individuals who are positive for a single biochemical autoantibody, on two separate blood samples during Screening will be eligible for entry into Phase 2 of the study. Individuals positive for at least two biochemical autoantibodies on the first blood sample obtained will be eligible for entry into Phase 2. Baseline Risk Assessment will include an oral glucose tolerance test (OGTT), HbA1c, ICA and HLA typing. A 20-minute intravenous glucose tolerance test (IVGTT) for First Phase Insulin Response (FPIR) may also be performed. Upon completion of Phase 2, participants will be classified into one of three risk categories for the occurrence of T1D within five years. Individuals who complete Phase 2 will then be eligible for Phase 3 and they will be seen at six-month intervals for five years. The primary study outcome is T1D by the American Diabetes Association criteria.