MULTICENTER INTERVENTION TRIAL TO PREVENT INSULIN-DEPENDENT DIABETES MELLITUS

预防胰岛素依赖型糖尿病的多中心干预试验

• 批准号: 6219295
• 负责人: DARRELL M WILSON
• 金额: $ 0.06万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6219295
• 关键词: autoantibody; clinical research; clinical trials; diabetes mellitus genetics; disease /disorder prevention /control; disease /disorder proneness /risk; family genetics; glucose tolerance test; human subject; insulin; insulin dependent diabetes mellitus; pancreatic islet function

We are currently screening the relatives of Type I diabetes to find subjects at high risk for developing Type I diabetes. Initial screening involves a single blood test to detect islet cell antibodies (ICA). ICA positive subjects are then staged primarily by examining the first phase insulin release during an IV glucose test. Each subject risk for developing Type I diabetes is calculated using an algorithm based on historical data. Subjects with a greater than 50% of developing Type I diabetes in the next five years are randomized into the parentral trial of IV and SQ insulin. Subjects with a 25 to 50% risk of developing Type I diabetes are randomized into the po insulin trial.

我们目前正在筛查I型糖尿病的亲属，以发现患I型糖尿病的高风险受试者。最初的筛查包括一个单一的血液测试，以检测胰岛细胞抗体（伊卡）。伊卡阳性受试者然后主要通过在IV葡萄糖测试期间检查第一时相胰岛素释放来分期。使用基于历史数据的算法计算每例受试者发生I型糖尿病的风险。在接下来的五年中，有超过50%的受试者发展为I型糖尿病，被随机分配到IV和SQ胰岛素的胃肠外试验中。将具有25 - 50%发展为I型糖尿病的风险的受试者随机分配到口服胰岛素试验中。