Trial to Reduce IDDM in the Genetically at Risk (TRIGR) Data Management Unit

在遗传风险 (TRIGR) 数据管理单元中进行减少 IDDM 的试验

基本信息

批准号：
8486297
负责人：
JEFFREY P KRISCHER
金额：
$ 72.45万
依托单位：
UNIVERSITY OF SOUTH FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-07-10 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8486297
关键词：
10 year old 6 year old Address Adherence Adverse event Affect Ancillary Study Antibodies Autoantibodies Autoimmunity Breast Feeding Caseins Cattle Child Clinical Clinical Trials Data Monitoring Committees Control Groups Country DNA Data Development Diabetes Mellitus Diabetes prevention Dietary Proteins Double-Blind Method Drops Early Diagnosis Electronics Enrollment European Exposure to Extravasation Family First Degree Relative Frequencies Funding Genotype Human Immunity Incidence Individual Infant Infant formula Infection Insulin-Dependent Diabetes Mellitus International Intervention Intestines Life Measurement Measures Medical Metabolic Milk Milk Proteins Monitor Mothers Natural History Nutrient Nutritional Online Systems Patient Care Peripheral Blood Mononuclear Cell Pilot Projects Population Prediabetes syndrome Primary Prevention Proteins Protocols documentation Quality Control Randomized Controlled Trials Relative Risks Reporting Research Design Risk Risk Factors Rodent Rodent Model Role Safety Self Tolerance Serum Societies System T cell response T-Lymphocyte Testing Weaning base casein hydrolysate clinical research site cost crosslink data management diabetes mellitus genetics diabetes risk disorder risk indexing infancy islet meetings prevent protein complex repository serological marker therapy design

项目摘要

DESCRIPTION (provided by applicant): The Trial to Reduce Insulin Dependent Diabetes in the Genetically at Risk ('TRIGR') will determine whether weaning to a formula in which (foreign) proteins have been extensively hydrolysed, reduces disease risk for Type 1 Diabetes (T1D) in genetically susceptible children, as it does in rodent models. The Specific Aims are: I-a: To determine whether weaning to a hydrolysed casein formula (Nutramigen") reduces the frequency of diabetes-predictive autoantibodies, and I-b: To determine whether weaning to casein hydrolysate reduces the frequency of clinical diabetes. This double blind, randomized controlled trial in subjects with an affected first degree relative and risk-associated HLA genotypes is currently in its 9th year. An international, multicenter consortium has been developed comprising 77 centers in 15 countries. Enrollment of 2160 eligible infants was completed successfully, providing a cushion above the required 2032 infants. The 6-8 month intervention designed to compare the effects of either hydrolysed casein or standard cow milk based weaning formula was completed in 2007. Duration of breast feeding at the mothers' discretion was similar to or above background populations All subjects are followed during and after the intervention period for at least 10 years with measurements of serological markers of intact cow milk exposure, diabetes predictive autoantibodies (the end point at age 6 years) and the clinical and/or metabolic indices of diabetes (the end point at age 10 years). Currently all planning parameters have been met and drop out rates are < 2% with compliance at expected levels. A large, cross-linked repository of stored sera, DNA T-cell data and and cryopreserved peripheral blood mononuclear cells allows independently funded ancillary and mechanistic studies related to the natural history of prediabetes and the hypothesis to be tested. This application covers years 11- 15 for the Data Management Unit for this 17 year study which is submitted in tandem with those of the European coordinating and clinical centers and those of the US coordinating and clinical centers.

描述（由申请人提供）：减少遗传上胰岛素依赖性糖尿病的试验（“ Trigr”）将确定对（外源）蛋白质对（外源）蛋白质广泛水解的公式的断奶，降低了在遗传上有遗传示意性儿童（T1D）的疾病风险，就像IT中一样。具体目的是：I-A：确定对水解酪蛋白配方（Nutramigen”）是否会降低糖尿病可预测性的自身抗体的频率，而I-B：确定对酪蛋白水解的断奶是否会降低临床糖尿病的频率，并降低了临床糖尿病的频率。目前，在15个国家 /地区开发了一个国际多中心财团，其中包括2160个合格的婴儿。在干预期间和之后，所有受试者至少遵循10岁的血清学标记，糖尿病的糖尿病预测性自身抗体（6岁时的终点）以及糖尿病的临床和/或代谢 - 目前的临床和/或代谢量很大。储存的血清，DNA T细胞数据和冷冻保存的外周核细胞的交联储存库允许独立资助的辅助和机理研究与糖尿病的自然历史有关临床中心。