Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes
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
- 否
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
Only 0.9% sodium chloride 250 ml was given for this group.
干预措施: Alpha lipoic acid (Drug)
alpha-lipoic acid group
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
Xiang Guang-da
Director of Endocrinol Dept.
Wuhan General Hospital of Guangzhou Military Command
