NATURAL HISTORY OF THE DEVELOPMENT OF TYPE 1 DIABETES

1 型糖尿病发展的自然史

• 批准号: 7606405
• 负责人: HENRY RODRIGUEZ
• 金额: $ 6.9万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606405
• 关键词: American; Autoantibodies; B-Lymphocytes; Biochemical; Blood specimen; Categories; Clinical Treatment; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Development; Diabetes Mellitus; Diabetes prevention; Funding; Future; Genetic; Glycosylated hemoglobin A; Goals; Grant; Immunologics; Individual; Informed Consent; Institution; Insulin-Dependent Diabetes Mellitus; Metabolic; Natural History; Newly Diagnosed; OGTT; Outcome Study; Pancreas; Participant; Pathogenesis; Persons; Phase; Procedures; Purpose; Qualifying; Research; Research Personnel; Resources; Risk; Risk Assessment; Sampling; Screening procedure; Second Degree Relative; Source; Testing; United States National Institutes of Health; Ursidae Family; Visit; cohort; design; follow-up; intravenous glucose tolerance test; prospective

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 TrialNet 联盟的主要目的是针对有患 1 型糖尿病 (T1D) 风险或新诊断出 T1D 的个体开展保护胰腺 B 细胞治疗的临床试验。 TrialNet T1D 发展自然史研究的目标是获取有关 T1D 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 T1D 预防试验的个体。 该研究分为三个阶段：每个阶段都需要单独的知情同意才能进入。 将使用前瞻性队列设计。 第一阶段包括对患有 1 型糖尿病的一级或二级亲属的人的血液样本中是否存在与 1 型糖尿病相关的生化自身抗体进行筛查。 第 2 阶段（基线风险评估）包括 OGTT、HbA1c、ICA 和 HLA 分型。 在某些情况下，还将进行 IVGTT。 还将从所有参与者处获取并储存样本，用于未来进行 B 细胞破坏机制的免疫和代谢评估，以及与发生 T1D 风险相关的遗传研究。 第二阶段完成后，参与者将被分为五年内发生 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六个月接受一次检查。 每次就诊时，程序将包括 OGTT、自身抗体测试、HbA1c 和用于储存的血液样本。 主要研究结果是美国糖尿病协会 (ADA) 标准的糖尿病。