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临床试验/NCT01978405
NCT01978405Unknown4 期

Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes

Xiang Guang-da1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
200
试验地点
1
主要终点
The changes of endothelium-dependent arterial dilation before and after contrast administrated

研究概览

简要总结

Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and endothelial dysfunction in type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetes
  • nephropathy (stage 3 and 4)

排除标准

  • recive alpha lipoic acid
  • type 1 diabetes
  • nephropathy (stagte 1, 2 and 5)
  • hypersensitivity to contrast media
  • IV heart failure
  • lactic acidosis

研究组 & 干预措施

Placebo intervention group

Placebo Comparator

Only 0.9% sodium chloride 250 ml was given for this group.

干预措施: Alpha lipoic acid (Drug)

alpha-lipoic acid group

Experimental

Alpha lipoic acid 600 mg in 0.9% sodium chloride 250 ml was given before and after contrast agent was administrated.

干预措施: Alpha lipoic acid (Drug)

结局指标

主要结局

The changes of endothelium-dependent arterial dilation before and after contrast administrated

时间窗: 6 months

Contrast induced acte kidney injury

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Xiang Guang-da
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiang Guang-da

Director of Endocrinol Dept.

Wuhan General Hospital of Guangzhou Military Command

研究点 (1)

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