The TEDDY Study: Georgia/Florida Clinical Center

描述（由申请人提供）：青少年糖尿病的环境决定因素（TEDDY）研究于2003年由美国和欧洲的六个临床中心发起，包括我们的临床中心，以确定可能触发或防止胰岛自身免疫和1型糖尿病（T1D）发展的感染因子，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，深入了解其机制，并与更广泛的科学界分享收集的标本，以研究T1D的发病机制和预防。共有424,788名新生儿通过HLA-DR、DQ基因分型进行筛查，以确定T1D风险增加的儿童，8677名新生儿每年随访4次，直到4岁，此后每年随访两次，直到15岁。我们的临床中心已经招募了965名TEDDY参与者；截至2012年6月30日，其中35人出现持续的胰岛自身抗体，6人被诊断为T1D。本次多中心前瞻性队列研究续期申请的具体目的是：1)对8677例胰岛自身免疫、糖尿病和乳糜泻高危儿童的TEDDY队列进行5年以上随访；2)按照标准的TEDDY方案收集所有计划的生物标本和流行病学数据，包括密切监测样品和数据的性能和质量；3)在适当的时间使用巢式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（单独资助）合作分析和发布实验室和流行病学数据；5)通过临床中心研究人员和工作人员参与研究指导委员会和分委员会的工作，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，并制定新的策略来预防、延缓或逆转这种疾病。

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 965 TEDDY participants; of those 35 have developed persistent confirmed islet autoantibodies and 6 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 8677 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.