The Environmental Determinants of Diabetes in Youth: Washington 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进行筛查。DQ基因分型识别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。本临床中心更新申请的具体目的是：1。完成本中心对HLA-DR的贡献。对361,000名新生儿进行DQ筛查，并纳入7800名高危婴儿进行强化前瞻性随访，以实现TEDDY的总体目标。2. 完善策略，以保留纳入随访的受试者，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，包括密切监测工作表现和样本/数据质量。3. 确定研究对象中胰岛自身抗体和临床T1D的发展前景。4. 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。5. 与TEDDY数据协调中心（由单独合同资助）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，指导正在进行的TEDDY项目。

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 this Clinical Center renewal application are to: 1. Complete this Center's 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 the TEDDY Data Coordinating Center (funded by a separate contract). 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.