The Environmental Determinants of Diabetes in Youth: Washington Clinical Center

青少年糖尿病的环境决定因素：华盛顿临床中心

• 批准号: 8513065
• 负责人: William A. Hagopian
• 金额: $ 457.94万
• 依托单位: PACIFIC NORTHWEST RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-03-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8513065
• 关键词: 15 year old; 4 year old; Address; Affect; Age; Ancillary Study; Autoantibodies; Autoimmune Diseases; Autoimmunity; Biological; Biological Markers; Birth; Celiac Disease; Child; Child Development; Clinical; Cohort Studies; Collaborations; Colorado; Communities; Contracts; Country; DNA; Data; Data Coordinating Center; Development; Diabetes Mellitus; Diagnosis; Dietary Factors; Disease; Enrollment; Environment; Environmental Exposure; Environmental Risk Factor; Epidemiology; Ethnic Origin; Etiology; Europe; Event; Feces; Finland; Florida; Funding; Gender; Genes; Genetic; Genetic Polymorphism; Genotype; Germany; Goals; HLA-DR Antigens; Infant; Infection; Infectious Agent; Insulin; Insulin-Dependent Diabetes Mellitus; Laboratories; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Nested Case-Control Study; Newborn Infant; Outcome Study; Participant; Pathogenesis; Performance; Peripheral Blood Mononuclear Cell; Plasma; Prevention; Protocols documentation; Publishing; RNA; Research Design; Research Personnel; Resolution; Resources; Risk; Risk Estimate; Sampling; Scientist; Specimen; Sweden; Testing; Time; United States; United States National Institutes of Health; Washington; Work; Youth; cohort; design; diabetes risk; endocrine pancreas development; follow-up; gene environment interaction; high risk; improved; infancy; insight; islet; novel; prevent; prospective; public health relevance; repository; time use

DESCRIPTION (provided by applicant): The Environmental Determinants of Diabetes in the Young (TEDDY) study was initiated in 2003 by six clinical centers in the United States and Europe, including ours, to identify infectious agents, dietary factors, or other environmental exposures that may trigger or protect against the development of islet autoimmunity and type 1 diabetes (T1D). Additional long-term scientific goals include assessment of potential gene-environment interactions affecting development of islet autoimmunity or T1D, gaining insight on mechanisms, and sharing collected specimens with broader scientific community for studies of T1D pathogenesis and prevention. A total of 424,788 newborns have been screened by HLA-DR, DQ genotyping to identify children at increased risk for T1D and 8677 are followed four times a year until 4 years of age and twice a year thereafter until age 15. Our Clinical Center has enrolled 1,379 TEDDY participants; of those 41 have developed persistent confirmed islet autoantibodies and 9 have been diagnosed with T1D, as of 6/30/2012. The specific aims of this renewal application for our multi-center, prospective cohort study are to: 1) Follow the TEDDY cohort of 8,677 high-risk children for development of islet autoimmunity and diabetes and celiac disease for 5 more years; 2) Collect all planned biological specimens and epidemiological data according to the standard TEDDY protocol including close monitoring of performance and of the quality of samples and data; 3) Perform planned laboratory tests at appropriate times using a nested case-control study design to answer specific scientific questions and hypotheses pertinent to the TEDDY study goals; 4) Analyze and publish laboratory and epidemiological data in collaboration with the TEDDY Data Coordinating Center (funded separately), and 5) Guide the ongoing TEDDY project by participation of the Clinical Center investigators and staff in work of the study Steering Committee and sub-committees. A successful study outcome should allow better understanding of the etiology and pathogenesis of islet autoimmunity and T1D and the development of new strategies to prevent, delay, or reverse the disease.

描述（由申请人提供）：青少年糖尿病的环境决定因素 (TEDDY) 研究由美国和欧洲的六个临床中心（包括我们的临床中心）于 2003 年启动，旨在识别可能引发或预防胰岛自身免疫和 1 型糖尿病 (T1D) 发展的传染源、饮食因素或其他环境暴露。其他长期科学目标包括评估影响胰岛自身免疫或 T1D 发展的潜在基因-环境相互作用、深入了解机制以及与更广泛的科学界共享收集的标本以研究 T1D 发病机制和预防。 共有 424,788 名新生儿接受了 HLA-DR、DQ 基因分型筛查，以识别 T1D 风险增加的儿童，并且对 8677 名新生儿进行了每年四次随访，直至 4 岁，此后每年随访两次直至 15 岁。我们的临床中心已招募了 1,379 名 TEDDY 参与者；截至 2012 年 6 月 30 日，其中 41 人已出现持续性确认的胰岛自身抗体，其中 9 人被诊断患有 T1D。我们的多中心前瞻性队列研究的更新申请的具体目标是： 1) 继续跟踪 TEDDY 队列，该队列由 8,677 名高危儿童组成，以了解胰岛自身免疫、糖尿病和乳糜泻的发展情况，持续 5 年； 2) 根据标准 TEDDY 协议收集所有计划的生物标本和流行病学数据，包括密切监测样本和数据的性能和质量； 3) 使用巢式病例对照研究设计在适当的时间进行计划的实验室测试，以回答与 TEDDY 研究目标相关的具体科学问题和假设； 4) 与 TEDDY 数据协调中心（单独资助）合作分析和发布实验室和流行病学数据，以及 5) 通过临床中心研究者和工作人员参与研究指导委员会和小组委员会的工作来指导正在进行的 TEDDY 项目。成功的研究结果应该有助于更好地了解胰岛自身免疫和 T1D 的病因和发病机制，并制定预防、延迟或逆转疾病的新策略。