NCT01622777已完成2 期
Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy
Alejandra Guillermina Miranda Diaz1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Stage of diabetic polyneuropathy
研究概览
简要总结
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus
- •Glycated hemoglobin <12.0%
- •Signing of informed consent
- •Presence of an abnormality of nerve conduction study
- •Symptoms and signs of diabetic polyneuropathy
排除标准
- •Pregnancy and lactation
- •Foot ulcers
- •Treatment with statins
- •Antioxidant drug and/or supplements one month previous to enrolment
- •Inability to mobilize
- •Renal and/or hepatic failure
研究组 & 干预措施
Rosuvastatin
Experimental
20 mg daily of oral rosuvastatin
干预措施: Rosuvastatin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Stage of diabetic polyneuropathy
时间窗: 12 weeks
Severity of diabetic polyneuropathy
时间窗: 12 weeks
Severity according nerve conduction studies
Nerve conduction studies
时间窗: 12 weeks
Neuropathy symptoms and impairment scores
时间窗: 12 weeks
Lipid peroxidation
时间窗: 12 weeks
Nerve growth factor
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Alejandra Guillermina Miranda Diaz
Investigator of Cardiovascular Research Unit
University of Guadalajara
研究点 (1)
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