The Environmental Triggers of Diabetes (TEDDY) in Sweden

瑞典糖尿病的环境诱因 (TEDDY)

• 批准号: 7876976
• 负责人: AKE LERNMARK
• 金额: $ 105.84万
• 依托单位: LUND UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-03-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7876976
• 关键词: 15 year old; 4 year old; Adverse event; Affect; Age-Months; Alleles; Appearance; Autoantibodies; Autoantigens; Autoimmunity; Biological; Biological Assay; Birth; Blood; Blood typing procedure; Child; Chromosomes, Human, Pair 11; Clinical; Cohort Studies; Collaborations; Contracts; Data; Data Coordinating Center; Data Quality; Development; Diabetes Mellitus; Diagnosis; Dietary Factors; Disease; Dissection; Enrollment; Environmental Exposure; Environmental Risk Factor; Epidemiologic Studies; Epidemiology; Epitopes; First Degree Relative; Frequencies; Funding; General Population; Genes; Genetic Risk; Genotype; Goals; Incidence; Individual; Infection; Infectious Agent; Insulin; Insulin-Dependent Diabetes Mellitus; Islet Cell; Laboratories; Lead; Minisatellite Repeats; Monitor; Mothers; Mutate; Nested Case-Control Study; Newborn Infant; Participant; Pathogenesis; Patients; Performance; Phenotype; Population; Pregnancy; Protocols documentation; Psychological Factors; Publishing; Recording of previous events; Regulatory T-Lymphocyte; Research Design; Research Personnel; Risk; Role; Sampling; Screening procedure; Serologic tests; Specificity; Specimen; Study Subject; Sweden; T-Lymphocyte; Testing; Time; Umbilical Cord Blood; Virus; Work; cytokine; cytotoxic; diabetes risk; endocrine pancreas development; follow-up; genetic risk factor; high risk; high risk infant; islet; prevent; prospective; time use

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.

描述（由申请人提供）：竞争性续展申请适用于瑞典青少年糖尿病环境决定因素 (TEDDY) 研究临床中心。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 (T1D) 风险增加相关的传染源、饮食因素或其他环境暴露。 TEDDY 是一项观察性队列研究，其中年龄小于 4.5 个月且在一般人群中具有高风险 HLA 基因型的新生儿或患有 T1D 患者的一级亲属将被纳入。此次瑞典临床中心续展申请的具体目标是： 1) 完成该中心对 361,000 名新生儿的 HLA-DR.DQ 筛查以及将 7,800 名高危婴儿纳入强化前瞻性随访的贡献，以实现总体 TEDDY 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，包括密切监测表现和样本/数据质量。 3) 前瞻性地确定研究对象中胰岛自身抗体和临床 T1D 的发展。 4) 使用嵌套病例对照研究设计在适当的时间执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，一直持续到 2009 年 12 月 31 日。符合条件的儿童在 4 岁之前每年接受四次随访，此后每年接受两次直到 15 岁。瑞典符合条件的新生儿频率高达 7.9%，普通人群和一级亲属的入学率均为 70%。迄今为止，瑞典临床中心参与了该研究的 3500 名儿童中的 37%。三个孩子患有 T1 D。参与者将被跟踪至 15 岁。环境因素的识别将有助于更好地了解疾病发病机制，并产生预防、延迟或逆转 T1D 的新策略。