The Environmental Determinants of Diabetes in Youth: Washington Clinical Center

描述(由申请人提供)：青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，目的是确定引发或防止胰岛自身免疫和1型糖尿病(T1D)发展的环境因素。一个成功的研究结果应该允许更好地了解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。新生儿通过人类白细胞抗原-DR.DQ基因分型进行筛查，以确定那些T1D风险增加的新生儿。符合条件的儿童在4岁之前每年接受四次跟踪，此后每年接受两次跟踪，直到15岁。本次临床中心续签申请的具体目标是：1.完成本中心对361,000名新生儿的人类白细胞抗原-DR.DQ筛查的贡献，并将7,800名高危婴儿纳入强化前瞻性随访，以实现总体Teddy目标。2.改进战略，以留住登记参加后续行动的受试者，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，包括密切监测业绩和样本/数据质量。3.确定研究对象胰岛自身抗体和临床T1D的前瞻性发展。4.采用嵌套式病例对照研究设计，在适当的时间进行有计划的实验室测试，以回答与Teddy研究目标相关的具体科学问题和假设。5.与Teddy数据协调中心合作(由另一份合同资助)，分析和公布实验室和流行病学数据。6.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，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.