DIABETES PREVENTION TRIAL TYPE 1

糖尿病预防试验类型 1

• 批准号: 6220563
• 负责人: RICHARD JACKSON
• 金额: $ 0.07万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 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/6220563
• 关键词: biomarker; clinical research; clinical trials; diabetes education; diabetes mellitus genetics; diabetes mellitus therapy; disease /disorder prevention /control; human subject; human therapy evaluation; insulin dependent diabetes mellitus; pancreatic islet function

Randomized, controlled, multicenter clinical trial, in which subjects randomized to one group will have active intervention, while subjects randomized to the control group will be closely monitored and offered treatment at the earliest sign of Insulin-Dependent Diabetes Mellitus (IDDM). Type I or IDDM arises in genetically predisposed individuals as a consequence of immune mediated destruction of the pancreatic islet insulin secreting beta-cells. The onset of clinical symptoms of diabetes represents the end point of a chronic progressive decline in beta-cell function, and it appears only when the majority of beta-cells have been lost. Since IDDM develops insidiously, often years after the induction of the pathogenic immune-mediated destructive process, it can be predicted using immunological markers and tests of insulin secretion. The Diabetes Prevention Trial of Type-1 Diabetes (DPT1) has been designed to test whether intervention during the prodromal period of the disease can delay its clinical onset.

随机、对照、多中心临床试验，随机分配到一组进行积极干预，随机分配到对照组密切监测并在出现胰岛素依赖型糖尿病（IDDM）早期体征时给予治疗。I型或IDDM出现在遗传易感个体中，是胰岛分泌胰岛素的β细胞受到免疫介导破坏的结果。糖尿病临床症状的出现代表了β细胞功能慢性进行性衰退的终点，只有在大多数β细胞丧失时才会出现。由于IDDM的发展不明显，通常在诱导致病性免疫介导的破坏性过程数年后，可以使用免疫标志物和胰岛素分泌测试来预测。1型糖尿病预防试验（DPT1）旨在测试在疾病前驱期进行干预是否可以延缓其临床发作。