Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Rate of loss of creatinine clearance
研究概览
简要总结
Investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. Patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. The study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (Type 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetics with proteinuria willing to be seen weekly for the evaluation of renal function
排除标准
- •Associated active medical diseases that would not permit evaluation of stable renal disease over 18 months
研究组 & 干预措施
Treatment
Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin.
干预措施: CIIIT (Drug)
结局指标
主要结局
Rate of loss of creatinine clearance
时间窗: 18 months
次要结局
- Quality of life assessment(12 to 18 months)
- Change in cardiac autonomic function(12 to18 months)
- Change in retinal photos(12 to 18 months)
- Change in cardiac function(12 to 18 months)