The Environmental Triggers of Diabetes (TEDDY) in Sweden

描述（由申请人提供）：竞争性更新申请是针对年轻人糖尿病环境决定因素（TEDDY）研究的瑞典临床中心。这项多中心、多国、流行病学研究的主要目的是确定与胰岛自身免疫和1型糖尿病（T1 D）风险增加相关的感染因子、饮食因素或其他环境暴露。TEDDY是一项观察性队列研究，将入组年龄小于4.5个月且在一般人群中具有高风险HLA基因型的新生儿或T1 D患者的一级亲属。本次瑞典临床中心更新申请的具体目标是：1）完成该中心对361，000名新生儿的HLA-DR.DQ筛查和7，800名高危婴儿的入组，以实现TEDDY的总体目标。2)根据标准方案（包括密切监测性能和样本/数据质量），完善策略以保留入组随访的受试者并收集所有计划的生物样本和流行病学数据。3)确定研究受试者中胰岛自身抗体和临床T1 D的前瞻性发展。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检查，以回答与TEDDY研究目标相关的特定科学问题和假设。5)与TEDDY数据协调中心合作分析和发布实验室和流行病学数据（由单独的合同资助）。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小组委员会的工作，指导正在进行的TEDDY项目。招募工作于2004年9月开始，将持续到2009年12月31日。符合条件的儿童在4岁之前每年接受4次随访，此后在15岁之前每年接受2次随访。在瑞典，合格新生儿的频率高达7.9%，在一般人口和一级亲属中，入学率为70%。到目前为止，瑞典临床中心提供了37%的3500名儿童参加了这项研究。三个孩子患上了T1 D。参与者将被跟踪到15岁。环境因素的识别将导致更好地理解疾病的发病机制，并导致预防，延迟或逆转T1 D的新策略。

DESCRIPTION (provided by applicant): The competing renewal application is for the SWEDEN Clinical Center of The Environmental Determinants of Diabetes in the Young (TEDDY) study. The primary objective of this multi-center, multi-national, epidemiological study is the identification of infectious agents, dietary factors, or other environmental exposures that are associated with increased risk of islet autoimmunity and type 1 diabetes mellitus (T1D). TEDDY is an observational cohort study in which newborns who are less than 4.5 months of age and have high risk HLA genotypes in the general population or are first-degree relatives of patients affected with T1D will be enrolled. The specific aims of this SWEDEN 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. Recruitment stared in September 2004 and will continue until December 31, 2009. Eligible children are followed four times per year until 4 years of age and twice a year thereafter until 15 years of age. The frequency of eligible newborns in Sweden is as high as 7.9% and the rate of enrollment is 70% in both the general population and among first degree relatives. The SWEDEN Clinical Center is contributing 37% of the 3500 children enrolled in the study so far. Three children have developed T1 D. Participants will be followed to age 15 years. Identification of environmental factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1 D.