DIABETES CONTROL AND COMPLICATIONS TRIAL

糖尿病控制和并发症试验

• 批准号: 3550495
• 负责人: DAVID E GOLDSTEIN
• 金额: $ 36.09万
• 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 1994-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3550495
• 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; endocrine disorder chemotherapy; glycosylation; hemoglobin As; home health care; hormone therapy; 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.

该提案的目标是参与多中心 协作临床试验以确定是否严格控制血液 血糖水平可有效预防或改善血管疾病 胰岛素依赖型糖尿病的并发症。 中央 要检验的假设是血糖控制改变的程度 是慢性病发生和进展的重要危险因素 糖尿病血管并发症。 另一个需要检验的假设是 存在可以恢复糖尿病患者代谢状态的疗法 人尽可能接近正常并且这种疗法可以 有效且安全地应用于大量个体 很长一段时间。 该提案的具体目标是 确定患者是否接受强化治疗（连续 皮下注射胰岛素）可以实现比胰岛素更好的血糖控制 接受常规治疗的患者（每日两次注射 胰岛素）。 关于强化治疗，我们将确定（作为一部分） 多中心合作研究）如果患者的发病率高 如果治疗是安全的，那么可接受性是可能的。 两次治疗 将建立小组（强化治疗与常规治疗） 经过广泛的基线评估后，将在以下时间对患者进行监测： 定期进行 1) 血糖控制，使用以下结果 血红蛋白 Alc 测定以及其他方法，以及 2) 病理学 终点，例如通过立体彩色视网膜确定的视网膜病变 照片。 研究将分三个阶段进行，规划 协议，有限的可行性试验（两年），如果有指示，则全面 规模试验。 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了解， 并建议糖尿病患者的合理治疗方法 梅利图斯。