Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Alpha-lipoic acid regress the left ventricular mass
研究概览
简要总结
Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients.
Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with CAD might will be reduced if the investigators can find novel therapies to regress LVH.
Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can improve endothelial function in diabetic conditions. Hence, the main aim of this study was to assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Left ventricular hypertrophy
- •HbA1c below 7.0%
- •blood pressure <130/80 mmHg
排除标准
- •Patients were excluded if they were currently alpha-lipoic acid for one year, had a previous adverse reaction to alpha-lipoic acid.
- •hey were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.
- •Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.
研究组 & 干预措施
alpha-lipoic acid group
alpha-lipoic acid 600 mg daily for one year.
干预措施: alpha-lipoic acid (Drug)
结局指标
主要结局
Alpha-lipoic acid regress the left ventricular mass
时间窗: one year
Alpha-lipoic acid 600 mg daily for one year.
次要结局
- The change of endothelial dysfunction before and after alpha-lipoic acid intervention.(one year)
研究者
Xiang Guang-da
Director of Endocrinol Dept.
Wuhan General Hospital of Guangzhou Military Command