NATURAL HISTORY OF THE DEVELOPMENT OF TYPE 1 DIABETES

1 型糖尿病发展的自然史

• 批准号: 7379098
• 负责人: HENRY RODRIGUEZ
• 金额: $ 6.91万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379098
• 关键词: NATURAL; HISTORY; DEVELOPMENT; TYPE; DIABETES

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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。TrialNet联盟的主要目的是开发治疗方法的临床试验，以保护有患1型糖尿病(T1D)风险或新诊断为T1D的个人的胰腺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有资格进行T1D预防试验的个人。这项研究分为三个阶段：每个阶段都需要单独的知情同意才能进入。将采用前瞻性队列设计。第一阶段包括对与T1D有一级或二级亲属的人的血液样本进行与T1D相关的生化自身抗体的筛查。第2阶段(基线风险评估)包括OGTT、HbA1c、ICA和人类白细胞抗原分型。在某些情况下，还将进行IVGTT。还将从所有参与者那里获取和存储样本，以供未来进行带有B细胞破坏机制的免疫学和新陈代谢评估，以及与发生T1D风险相关的基因研究。第二阶段完成后，参与者将被归类为五年内发生T1D的三个风险类别之一。第三阶段(后续风险评估)有患1型糖尿病风险的受试者将在五年内每隔六个月接受一次检查。在每次就诊时，程序将包括OGTT、自身抗体测试、HbA1c和储存的血液样本。主要研究结果是美国糖尿病协会(ADA)标准的糖尿病。