TRIALNET NATURAL HISTORY STUDY OF THE DEVELOPMENT OF TYPE 1 DIABETES

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 TrialNet方案的设计类似于作为国家1型糖尿病预防试验(DPT-1)的一部分在TCH实施的研究。对于符合资格的受试者，计划在第二阶段或第三阶段开始进行GCRC的参观。第一阶段包括在芭芭拉·戴维斯中心的门诊环境中对1型糖尿病患者的亲属进行生化胰岛细胞抗体筛查。 TrialNet自然历史研究的所有实验室评估将由TCH以外的实验室进行测量。 如果只存在一种自身抗体，芭芭拉·戴维斯中心的工作人员将提取第二份样本，并提交确认阳性的自身抗体。如果得到确认，个人将有资格参加该方案的第二阶段，其中包括在GCRC的TCH进行口服葡萄糖耐量试验(OGTT)。其中一些参与者可能需要进行静脉葡萄糖耐量测试(IVGTT)，以评估他们患1型糖尿病的风险。这项测试也将在GCRC上进行。 对于在最初的血液样本评估中有两个或两个以上胰岛细胞自身抗体的个人，可以在第二阶段提取确认样本，如上所述，该阶段包括OGTT的表现。 在参加DPT-1期间接受代谢测试的个人将有资格参加TrialNet第三阶段的自然历史研究，该阶段包括每隔6个月进行一次OGTT。 随机选择的一组自身抗体阴性的参与者将有资格进入TrialNet自然历史研究第三阶段。这一组的代谢测试(仅限OGTT)将每年在GCRC上进行。 TrialNet内可能需要使用GCRC服务的其他协议，将单独提交给GCRC和COMIRB，与这项“自然历史研究”分开提交。

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".