Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in sensory nerve conduction velocity from baseline to 6 mo of treatment
研究概览
简要总结
The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.
详细描述
It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have a duration of type 1 diabetes of more than 5 yrs
- •Subjects who are C-peptide deficient
- •Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
- •Subjects who have measurable action potential in the sural nerves
- •Subjects who have reduced nerve conduction velocity in the sural nerves
排除标准
- •Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
- •Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
- •Subjects who are transplanted (islet cell, kidney or pancreas)
结局指标
主要结局
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment
次要结局
- - Change in quantitative sensory tests and
- neurological impairment assessment from baseline to 6 mo of treatment
- - Safety and tolerability of C-peptide