The Environmental Determinants of Diabetes in Youth: Washington Clinical Center

描述(申请人提供)：青年糖尿病的环境决定因素(Teddy)研究于2003年由包括我们在内的美国和欧洲的六个临床中心发起，旨在确定可能引发或预防胰岛自身免疫和1型糖尿病(T1D)发展的感染源、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，并与更广泛的科学界共享收集的标本，用于T1D发病机制和预防的研究。共有424,788名新生儿接受了HLADR，DQ基因分型，以确定T1D风险增加的儿童，其中8677名新生儿接受了每年四次跟踪，直到4岁，此后每年两次跟踪，直到15岁。我们的临床中心招募了1,379名Teddy参与者；其中41人发展为持续性胰岛自身抗体，其中9人被诊断为T1D，截至2012年6月30日。我们多中心前瞻性队列研究更新申请的具体目的是：1)跟踪8,677名患有胰岛自身免疫以及糖尿病和乳糜泻的高危儿童的Teddy队列5年以上；2)根据标准Teddy方案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质量；3)在适当的时间使用嵌套病例对照研究设计进行计划的实验室测试，以回答与Teddy研究目标相关的特定科学问题和假设；4)与Teddy数据协调中心(单独出资)合作分析和发布实验室和流行病学数据，以及5)通过临床中心调查人员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。一个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，并开发新的预防、延迟或逆转疾病的策略。

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.