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）是一项多中心前瞻性队列研究，于2003年启动，旨在确定触发或保护胰岛自身免疫和1型糖尿病（T1D）发展的环境因素。一个成功的研究结果应该有助于更好地了解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。新生儿通过HLA-DR、DQ基因分型进行筛查，以确定T1D风险增加的人群。符合条件的儿童每年随访四次，直到4岁，此后每年随访两次，直到15岁。GA/FL临床中心更新申请的具体目的是：1)完成对36.1万例新生儿HLA-DR、DQ筛查和7800例高危婴儿纳入强化前瞻性随访的贡献，以实现TEDDY总体目标；2)完善保留随访受试者的策略，并根据标准方案收集所有计划的生物标本和流行病学数据，包括密切监测绩效和样本/数据质量；3)确定研究对象中胰岛自身抗体和临床T1D的前景发展，4)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，5)与其他TEDDY临床中心和数据协调中心合作，分析和发布实验室和流行病学数据。6)通过临床中心研究者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。这些拟议的活动对于实现以下长期科学目标至关重要：1)确定触发或阻止胰岛自身抗体或T1D发展的环境因素（感染、饮食、社会心理因素、毒素、过敏原等）2)评估潜在的基因-环境相互作用，以提高对影响胰岛自身免疫或T1D发展的环境因素的识别，并深入了解其机制。3)收集和保存标本，用于T1D发病机制的研究和T1D预测生物标志物的开发。对TEDDY受试者的前瞻性标本收集为TEDDY联盟内外的科学家提供了一个独特的机会，通过执行否则不可能的批判性研究来测试新的假设。

DESCRIPTION (provided by applicant): The Environmental Determinants of Diabetes in the Young (TEDDY), a multicenter prospective cohort study, was initiated in 2003 to identify environmental factors that trigger or protect against the development of islet autoimmunity and type 1 diabetes (T1D). A successful study outcome should allow better understanding of the etiology and pathogenesis of T1D and the development of new strategies to prevent, delay, or reverse the disease. Newborns are screened by HLA-DR,DQ genotyping to identify those at increased risk for T1D. Eligible children are followed four times per year until 4 years of age and twice a year thereafter until 15 years of age. The specific aims of the GA/FL Clinical Center renewal application are to: 1) Complete our contribution to the HLA-DR,DQ screening of 361,000 newborns and enrollment of 7,800 high-risk infants into intensive prospective follow-up to achieve the overall TEDDY goals, 2) Refine strategies to retain subjects enrolled in the follow-up and collect all planned biological specimens and epidemiological data according to the standard protocol including close monitoring of performance and sample/data quality, 3) Ascertain prospectively development of islet autoantibodies and clinical T1D in the study subjects, 4) 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, 5) Analyze and publish laboratory and epidemiological data in collaboration with other TEDDY clinical centers and the Data Coordinating Center, 6) Guide the ongoing TEDDY project by participation of the Clinical Center investigators and staff in work of the study Steering Committee and sub-committees. These proposed activities are essential to achieve the following long-term scientific goals: 1) To identify environmental factors (infectious, dietary, psychosocial factors, toxins, allergens, etc) that trigger or protect against the development of islet autoantibodies or T1 D. 2) To assess potential gene-environment interactions to improve identification of environmental factors affecting development of islet autoimmunity or T1D, and to gain insight on mechanisms. 3) Collect and bank specimens for studies of T1D pathogenesis and development of biomarkers for T1D prediction. The prospectively collected specimens on TEDDY subjects provide a unique opportunity for scientists within and outside the TEDDY consortium to test novel hypotheses by performing otherwise impossible critical studies.