THE TEDDY STUDY - COLORADO CLINICAL CENTER

泰迪研究 - 科罗拉多临床中心

• 批准号: 8293316
• 负责人: MARIAN J REWERS
• 金额: $ 90.78万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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/8293316
• 关键词: 15 year old; 4 year old; 5 year old; Address; Affect; Age; Age-Months; Alleles; Appearance; Autoantibodies; Autoimmunity; Award; Biological; Birth; Birth Order; Blood Screening; Cells; Cereals; Child; Childhood; Clinical; Cohort Studies; Collaborations; Colorado; Contracts; Cytomegalovirus; DNA; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Day Care; Development; Diabetes Mellitus; Diabetes autoantibodies; Diet; Dietary Factors; Disease; Enrollment; Enterovirus; Environment; Environmental Exposure; Environmental Risk Factor; Epidemiology; Epitopes; Ethnic Origin; Etiology; Europe; Evaluation; Exposure to; Family history of; First Degree Relative; Frequencies; Funding; General Population; Genes; Genetic; Genetic Markers; Genetic Polymorphism; Genetic Risk; Genotype; Goals; HLA-A gene; HLA-DR Antigens; HLA-DR3 Antigen; HLA-DRB1; Haplotypes; Herpesvirus 1; Household; Human Herpesvirus 2; IA-2 protein; IgG4; Immunization; Immunoglobulin Class Switching; Immunoglobulin G; Incidence; Infant; Infection; Infectious Agent; Insulin; Insulin-Dependent Diabetes Mellitus; Intake; Intercellular adhesion molecule 1; Laboratories; Life; Measurement; Meat; Monitor; Natural History; Neonatal Screening; Nested Case-Control Study; Newborn Infant; Outcome Study; Parents; Pathogenesis; Patients; Performance; Persons; Population; Prediabetes syndrome; Production; Protocols documentation; Publishing; Race; Regulatory T-Lymphocyte; Relative (related person); Research Design; Research Personnel; Risk; Rotavirus; Sampling; Screening procedure; Siblings; Specimen; Study Subject; Supplementation; Testing; Time; Umbilical Cord Blood; United States; Vaccination; Vaccines; Viral; Viral Antibodies; Vitamin D3 Receptor; Vitamins; Woman; Work; case control; cohort; diabetic; early childhood; endocrine pancreas development; environmental agent; experience; follow-up; fruits and vegetables; gene environment interaction; high risk; high risk infant; human leukocyte antigen gene; in utero; islet; men; offspring; pet animal; prevent; proband; programs; promoter; prospective; response; time use; transmission process; viral RNA

DESCRIPTION (provided by applicant): This competing renewal application is for the Colorado Clinical Center of The Environmental Determinants of Diabetes in the Young (TEDDY) study. The primary objective of this multi-center, prospective cohort study initiated in 2003 is the identification of infectious agents, dietary factors, or other environmental exposures that trigger or protect against the development of islet autoimmunity and type 1 diabetes (T1D). 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. Six Clinical Centers in the United States and Europe will screen 361,588 newborns and enroll 7,801 those eligible for prospective follow-up. The specific aims of this Clinical Center renewal application are to: 1. Complete this Center's contribution to the HLA-DR.DQ screening and enrollment of 7,801 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. 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.

描述（由申请人提供）：这种竞争性更新申请是在年轻（泰迪）研究中针对糖尿病环境决定因素的科罗拉多州临床中心。这项在2003年启动的多中心，前瞻性队列研究的主要目标是鉴定传染性药物，饮食因素或其他环境暴露，触发或防止胰岛自身免疫性和1型糖尿病（T1D）的发展。新生儿由HLA-DR和DQ基因分型筛选，以识别患有T1D风险增加的人。符合条件的儿童每年四次，直到4岁，此后每年两次，直到15岁。美国和欧洲的六个临床中心将筛选361,588名新生儿，并招募7,801名有资格进行预期随访的新生儿。该临床中心续签应用的具体目的是：1。完成该中心对HLA-DR.DQ筛查的贡献，并将7,801名高危婴儿纳入密集的前瞻性随访，以实现整体播发目标。 2。根据标准方案，包括对后续行动的受试者的保留策略，并根据标准协议收集所有计划的生物学标本和流行病学数据，包括对性能和样本/数据质量的密切监视。 3。在研究对象中确定胰岛自身抗体和临床T1D的前瞻性开发。 4.使用嵌套的病例对照研究设计在适当时间进行计划的实验室测试，以回答与泰迪研究目标有关的特定科学问题和假设。 5。与泰迪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。通过临床中心研究人员和工作人员参加研究指导委员会和小组委员会的工作，指导正在进行的泰迪项目。成功的研究结果应使得对T1D的病因和发病机理以及预防，延迟或扭转疾病的新策略的发展。