Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation.
详细描述
The present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation. The sample size was estimated to be 92 (23 in each group). The participants of the study were selected from the non-diabetic patients scheduled for CABG. The patients were allocated to four groups using balanced block randomization method:
- Consumption of the supplement (a 20 gram pack of the supplement daily) 7 days before surgery and placebo (a pack of starch) 30 days post surgery
- Consumption of placebo 7 days before surgery and supplement 30 days post surgery
- Consumption of the supplement 7 days before and 30 days post surgery
- Consumption of placebo 7 days before and 30 days post surgery One week before, before the onset of the surgery, after the surgery, 1 week after and 4 weeks after the operation, blood samples were taken and the levels of hemoglobin A1C, glucose, insulin and malondialdehyde were measured. Also, body composition indices were assessed in four times: one week before the surgery, before the onset of the surgery, 1 week after and 4 weeks after the surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean age of 30-70 years old, Having Coronary Artery Disease
- •Undergoing coronary artery bypass grafting surgery
排除标准
- •Positive history of diabetes mellitus, metabolic, hematological, and immune disorders, renal problem, and cerebrovascular accident
- •Taking antioxidant supplements
- •Cases for emergency operations
- •Ejection Fraction < 30%
研究组 & 干预措施
Supplement pre CABG
Consumption of the supplement 7 days before surgery and placebo 30 days post surgery
干预措施: Supplement pre CABG (Dietary Supplement)
Supplement post CABG
Consumption of placebo 7 days before surgery and supplement 30 days post surgery
干预措施: Supplement post CABG (Dietary Supplement)
Supplement pre and post CABG
Consumption of the supplement 7 days before and 30 days post surgery
干预措施: Supplement pre and post CABG (Dietary Supplement)
Placebo
Consumption of placebo 7 days before and 30 days post surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Hemoglobin A1C
时间窗: 37 days
It was measured in 4 steps: 1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation
Serum glucose
时间窗: 37days
It was measured in 5 steps: 1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation
Insulin Resistance
时间窗: 37 days
Calculated by HOMA calculation equation It was calculated in 5 steps: 1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation
serum insulin
时间窗: 37 days
It was measured in 5 steps: 1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation
次要结局
- malondialdehyde(37 days)
- Body Composition changes(37 days)
研究者
Mohammad Hassan Eftekhari
Professor. PhD
Shiraz University of Medical Sciences