DIABETES CONTROL AND COMPLICATIONS TRIAL

糖尿病控制和并发症试验

• 批准号: 3550493
• 负责人: DAVID E GOLDSTEIN
• 金额: $ 53.47万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 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/3550493
• 关键词: adolescence (12-20); artificial endocrine pancreas; blood chemistry; blood glucose; clinical trials; cooperative study; diabetes mellitus therapy; diabetic angiopathy; diabetic neuropathy; diabetic retinopathy; diet therapy; glycosylation; hemoglobin As; home health care; human subject; human therapy evaluation; insulin; insulin dependent diabetes mellitus; longitudinal human study; medical complication; metabolism disorder diagnosis; nervous system disorder diagnosis; nutrition related tag; psychological tests; self care; therapy compliance; urinalysis; young adult human (21-34)

The objective of this proposal is to participate in a multicenter collaborative clinical trial to determine whether strict control of blood glucose levels is effective in preventing or ameliorating the vascular complications of insulin-dependent diabetes mellitus. The central hypothesis to be tested is that the degree of altered blood glucose control is an important risk factor in the development and progression of chronic diabetic vascular complcations. Another hypothesis to be tested is that a therapy exists which will restore the metabolic state of the diabetic person to as close to normal as possible and that this therapy can be effectively and safely applied to a large number of individuals over a prolonged period of time. The specific aims of the proposal are to determine if patients treated with an intensive regimen (continuous subcutaneous insulin infusion) can achieve better glucose control than patients treated with a conventional regimen (two daily injections of insulin). In respect to the intensive therapy, we will determine (as part of the multicenter collaborative study) if high rates of patient acceptability are possible and if the treatment is safe. Two treatment groups (intensive vs conventional therapy) will be established and following an extensive baseline evaluation, patients will be monitored at regular intervals for 1) blood glucose control using the results of hemoglobin Alc determinations as well as other means, and for 2) pathologic endpoints such as retinopathy as determined by stereo color trtinal photographs. The study will proceed in three phases, planning of protocols, limited feasibility trial (two years) and if indicated, full scale trial. The proposed studies will provide important new information which will increase our understanding of diabetic vascular complications, and suggest rational approaches to treatment of patients with diabetes mellitus.

该提议的目的是参加多中心 协作临床试验以确定严格控制血液 葡萄糖水平有效预防或改善血管 胰岛素依赖性糖尿病的并发症。 中央 要测试的假设是血糖控制的改变程度 是慢性发展和发展的重要危险因素 糖尿病血管申诉。 要检验的另一个假设是 存在治疗将恢复糖尿病的代谢状态 人们尽可能接近正常，这种疗法可以是 有效，安全地应用于大量个人 长时间的时间。 该提案的具体目的是 确定患者是否接受密集治疗（连续） 皮下胰岛素输注）比 接受常规方案治疗的患者（每天两次注射 胰岛素）。 关于强化疗法，我们将确定（作为一部分 多中心协作研究）如果患者率高 可接受性是可能的，如果治疗是安全的。 两种治疗方法 将建立组（密集与常规疗法），并 经过广泛的基线评估，将在 使用的定期间隔1）使用的结果 血红蛋白ALC测定以及其他手段，以及2）病理学 终点，例如由立体声颜色trtinal确定的视网膜病变 照片。 该研究将分为三个阶段，计划 协议，有限的可行性试验（两年），如果有指示，则 比例试验。 拟议的研究将提供重要的新信息 这将增加我们对糖尿病血管并发症的理解， 并提出了治疗糖尿病患者的理性方法 Mellitus。