DIABETES PREVENTION TRIAL TYPE 1

糖尿病预防试验类型 1

• 批准号: 6120783
• 负责人: RICHARD JACKSON
• 金额: $ 3.04万
• 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/6120783
• 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，受试者 随机分成一组进行积极干预，而受试者 随机分配给对照组的人将受到密切监测并提供 胰岛素依赖型糖尿病的早期治疗 (IDDM)。I型或IDDM出现在遗传易感人群中，表现为 免疫介导的胰岛破坏的后果 分泌胰岛素的β细胞。糖尿病临床症状的出现 代表胰岛β细胞慢性进行性下降的终点 功能，只有当大多数β细胞 迷路了。由于IDDM是潜伏发展的，通常是在诱导数年后 在致病免疫介导的破坏性过程中，它可以是 使用免疫标记物和胰岛素分泌试验进行预测。 1型糖尿病预防试验(DPT1)已经完成 旨在测试在先兆期间是否进行干预 疾病可以推迟其临床发病。