The Environmental Triggers of Diabetes (TEDDY)

糖尿病的环境诱因 (TEDDY)

基本信息

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
项目类别：
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

项目摘要

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）：青少年糖尿病的环境决定因素 (TEDDY) 研究由美国和欧洲的 6 个临床中心于 2004 年发起，筛查了 424,732 名新生儿，纳入了 8,669 名 HLA 增加的儿童（瑞典 2525 名） 1 型糖尿病 (T1D) 的风险。我们在本次更新申请中进行的多中心、前瞻性队列研究的主要目标是识别可能引发或预防胰岛自身免疫和 T1D 以及乳糜泻的传染源、饮食因素和其他环境暴露。 T1D 的常见合并症。登记的婴儿每年接受四次随访，直到 4 岁，此后每年接受两次随访，直到 15 岁。2013 年，最小的孩子将是 3 岁，最大的孩子将是 8 岁。迄今为止，已有 425 名儿童（瑞典 145 名）患有持久性胰岛自身抗体，117 名儿童（瑞典 30 名）患有 T1D。此次更新申请的具体目标是： 1) 继续跟踪由 8,669 名高危儿童组成的 TEDDY 队列 5 年以上的胰岛自身免疫、糖尿病和乳糜泻发展情况； 2）根据标准TEDDY方案收集所有计划的生物标本和流行病学数据，持续保持高保留率和合规性，并密切监测样本和数据质量； 3) 使用巢式病例对照研究设计在适当的时间进行计划的实验室分析，以回答与 TEDDY 研究目标相关的具体科学问题和假设； 4) 与 TEDDY 数据协调中心（由单独的 UC4 合同资助）合作分析和发布实验室和流行病学数据，以及 5) 通过瑞典 TEDDY 诊所研究人员和工作人员参与研究工作来指导正在进行的 TEDDY 项目委员会和小组委员会。这些目标对于以下长期科学目标至关重要：A) 确定触发或防止特定胰岛自身抗体（针对胰岛素、GAD65、IA-2 以及 ZnT8）或临床 T1D 发展的环境因素； B) 评估影响胰岛自身免疫或 T1D 发展的潜在基因-环境相互作用，并深入了解机制； C) 收集和储存标本，用于研究 T1D 发病机制和开发 T1D 预测生物标志物。成功的研究结果应该有助于更好地了解胰岛自身免疫和 T1D 的病因和发病机制，从而指导制定预防、延迟或逆转疾病的新策略。