The Environmental Triggers of Diabetes (TEDDY)

糖尿病的环境诱因 (TEDDY)

• 批准号: 8510746
• 负责人: AKE LERNMARK
• 金额: $ 572.97万
• 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 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8510746
• 关键词: 15 year old; 20 year old; 3 year old; 4 year old; 8 year old; Accounting; Address; Affect; Age; Age-Months; Ancillary Study; Autoantibodies; Autoimmune Diseases; Autoimmune Process; Autoimmunity; Beta Cell; Biological; Biological Markers; Birth; Celiac Disease; Child; Child Development; Chronic Disease; Clinic; Clinical; Cohort Studies; Collaborations; Comorbidity; Contracts; DNA; Data; Data Coordinating Center; Data Quality; Development; Diabetes Mellitus; Diabetes prevention; Diagnosis; Diet; Dietary Factors; Disease; Enrollment; Environmental Exposure; Environmental Risk Factor; Epidemiology; Etiology; Europe; Event; Family health status; Feces; Funding; Genes; Genetic; Genetic Polymorphism; Genotype; Goals; HLA-DR Antigens; Health Care Costs; Healthcare Systems; Immune system; Individual; Infant; Infectious Agent; Insulin; Insulin-Dependent Diabetes Mellitus; Islet Cell; Islets of Langerhans; Knowledge; Laboratories; Life; Manuals; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Nested Case-Control Study; Newborn Infant; North America; Outcome Study; Participant; Pathogenesis; Patients; Performance; Peripheral Blood Mononuclear Cell; Plasma; Population; Prevalence; Protocols documentation; Publishing; RNA; Research; Research Design; Research Personnel; Resolution; Resources; Risk; Risk Estimate; Sampling; Scientist; Site; Specimen; Sweden; Symptoms; Technology; Testing; Time; United States; United States National Institutes of Health; Virus Diseases; Work; burden of illness; cohort; design; diabetes risk; endocrine pancreas development; gene environment interaction; high risk; improved; insight; islet; novel; operation; prevent; prospective; public health relevance; repository; time use; young adult

DESCRIPTION (provided by applicant): The Environmental Determinants of Diabetes in the Young (TEDDY) study was initiated in 2004 by six clinical centers in the United States and Europe, and screened 424,732 newborns to enroll 8,669 children (2525 in Sweden) at increased HLA risk for type 1 diabetes (T1D). The primary objective of our multi-center, prospective cohort study in this renewal application is the identification of infectious agents, dietary factors, and other environmental exposures that may trigger or protect against the development of islet autoimmunity and T1D as well as celiac disease, a common co-morbidity to T1D. Enrolled infants are followed four times per year until age 4 and twice a year thereafter until age 15. In 2013, the youngest children will be 3 and the oldest 8 years of age. So far, 425 children (145 in Sweden) have developed persistent islet autoantibodies and 117 (30 in Sweden) have developed T1D. The specific aims of this renewal application are to: 1) Follow the TEDDY cohort of 8,669 high-risk children for development of islet autoimmunity and diabetes and celiac disease for 5 more years; 2) Collect all planned biological specimens and epidemiological data according to the standard TEDDY protocol with continued high retention and compliance and close monitoring of sample and data quality; 3) Perform planned laboratory analyses at appropriate times using a nested case-control study design to answer specific scientific questions and hypotheses pertinent to the TEDDY study goals; 4) Analyze and publish laboratory and epidemiological data in collaboration with the TEDDY Data Coordinating Center (funded by a separate UC4 contract), and 5) Guide the ongoing TEDDY project by participation of Sweden TEDDY clinic investigators and staff in the work of the study Steering Committee and sub-committees. These aims are crucial to the long-term scientific goals to A) to identify environmental factors that trigger or protect against the development of defined islet autoantibodies (against insulin, GAD65, IA-2 as well as ZnT8) or clinical T1D; B) to assess potential gene-environment interactions affecting development of islet autoimmunity or T1D, and to gain insight on mechanisms; and C) to collect and bank specimens for studies of T1D pathogenesis and development of biomarkers for T1D prediction. A successful study outcome should allow better understanding of the etiology and pathogenesis of islet autoimmunity and T1D, thereby guiding development of new strategies to prevent, delay, or reverse the disease.

描述（由申请人提供）：年轻人糖尿病的环境决定因素（TEDDY）研究于2004年由美国和欧洲的六个临床中心发起，筛选了424，732名新生儿，招募了8，669名HLA风险增加的1型糖尿病（T1 D）儿童（瑞典为2525名）。在本次更新申请中，我们的多中心、前瞻性队列研究的主要目的是确定可能引发或预防胰岛自身免疫和T1 D以及乳糜泻（T1 D的常见合并症）发展的感染原、饮食因素和其他环境暴露。登记的婴儿每年随访四次，直到4岁，此后每年随访两次，直到15岁。到2013年，最小的孩子将3岁，最大的8岁。到目前为止，有425名儿童（瑞典145名）出现持续性胰岛自身抗体，117名（瑞典30名）出现T1 D。本次更新申请的具体目的是：1）对8，669名胰岛自身免疫、糖尿病和乳糜泻高危儿童的TEDDY队列进行5年以上随访; 2）根据标准TEDDY方案收集所有计划的生物样本和流行病学数据，并继续保持高保留率和依从性，密切监测样本和数据质量; 3）在适当的时候使用巢式病例对照研究设计进行计划的实验室分析，以回答与TEDDY研究目标相关的特定科学问题和假设; 4）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UC 4合同资助），和5）通过瑞典TEDDY临床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来指导正在进行的TEDDY项目。这些目标对于长期科学目标是至关重要的：A）确定触发或防止定义的胰岛自身抗体发展的环境因素（针对胰岛素、GAD 65、IA-2以及ZnT 8）或临床T1 D; B）评估影响胰岛自身免疫或T1 D的发展的潜在基因-环境相互作用，并获得对机制的了解;及C）收集及储存样本以供研究T1 D发病机制及开发用于T1 D预测的生物标记物。一个成功的研究结果应该可以更好地了解胰岛自身免疫和T1 D的病因和发病机制，从而指导开发新的策略来预防，延迟或逆转疾病。