DIABETES CONTROL AND COMPLICATIONS TRIAL

糖尿病控制和并发症试验

• 批准号: 3550674
• 负责人: JOHN DUPRE
• 金额: $ 42.42万
• 依托单位: UNIVERSITY OF WESTERN ONTARIO
• 依托单位国家: 美国
• 财政年份: 1982
• 资助国家: 美国
• 起止时间: 1982-03-01 至 1993-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3550674
• 关键词: adolescence (12-20); adult human (21+); artificial endocrine pancreas; behavioral medicine; blood chemistry; blood glucose; blood lipid; cooperative study; diabetes education; diabetes mellitus therapy; diabetic angiopathy; diet therapy; drug administration rate /duration; drug delivery systems; epidemiology; fluorescein angiography; glycosylation; hemoglobin As; home health care; human subject; human therapy evaluation; insulin; insulin dependent diabetes mellitus; kidney disorder diagnosis; longitudinal human study; medical complication; metabolism disorder diagnosis; nervous system disorder diagnosis; nutrition education; nutrition related tag; psychological tests; self care; therapy compliance; urinalysis

The goal is to demonstrate prospectively whether or not the course of microvascular complications in insulin-dependent diabetes mellitus can be modified by altered glycemic control. The major question addressed is whether significantly different mean levels of glycemia can be maintained in comparable groups of volunteers with IDDM and whether these will be associated with different rates of evolution of microangiopathy. The feasibility of recruitment and randomization of volunteers to standard and experimental treatments as defined, and of attainment of different target levels of glycemic control in two groups, was demonstrated with participation of this clinic, through periods of more than 1 year in phase II of the study. It is proposed that patients will continue to be recruited according to the specified eligibility criteria. After giving informed consent volunteers will be randomized to the standard treatment with one or two injections of insulin a day, or to an experimental treatment based on multiple daily infections or continuous subcutaneous infusion of insulin. Glycemic control will be assessed according to measurements of blood glucose and hemoglobin A1C. The protocol incorporates safeguards against the risks of the treatments and has been judged ethically acceptable. During phases I and II of the study the University of Western Ontario (UWO, Clinic 18) has developed the staff and facilities required for phase III. Strategies for ensuring successful recruitment, for maintenance of adherence to the protocol, and for recognition and minimization of intercurrent events, are outlined. The summation of data from all DCCT clinics will be used to test the question whether the attainable relative improvement in glycemic control resulting from the experimental treatment as defined can prevent or ameliorate microvascular complications of Type I diabetes.

目标是前瞻性地证明该过程是否 胰岛素依赖型糖尿病的微血管并发症可 通过改变血糖控制进行修改。 解决的主要问题是 是否可以维持显着不同的平均血糖水平 在患有 IDDM 的志愿者的可比较群体中，以及这些是否会被 与微血管病的不同进化速度相关。 这 根据标准和标准招募和随机分配志愿者的可行性 定义的实验治疗以及不同目标的实现 两组的血糖控制水平通过 该诊所的参与，分阶段进行超过一年 二、研究内容。 建议患者继续 按照规定的资格条件聘用。 给予后 知情同意的志愿者将被随机分配接受标准治疗 每天注射一到两次胰岛素，或进行实验 基于每日多次感染或持续皮下注射的治疗 输注胰岛素。 血糖控制将根据 血糖和血红蛋白 A1C 的测量。 协议 纳入了针对治疗风险的保障措施，并已 被认为在道德上是可以接受的。 在研究的第一阶段和第二阶段 西安大略大学（UWO，诊所 18）培养了员工和 第三阶段所需的设施。 确保成功的策略 招募，以维持对协议的遵守，以及 概述了并发事件的识别和最小化。 这 所有 DCCT 诊所的数据总和将用于测试该问题 血糖控制是否可达到相对改善 根据定义的实验治疗可以预防或改善 I 型糖尿病的微血管并发症。