Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
- Conditions
- Coronary Artery Disease
- Interventions
- Dietary Supplement: Supplement pre and post CABGDietary Supplement: Supplement pre CABGDrug: PlaceboDietary Supplement: Supplement post CABG
- Registration Number
- NCT02184507
- Lead Sponsor
- Mohammad Hassan Eftekhari
- Brief Summary
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.
- Detailed Description
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:
1. 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
2. Consumption of placebo 7 days before surgery and supplement 30 days post surgery
3. Consumption of the supplement 7 days before and 30 days post surgery
4. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- Mean age of 30-70 years old, Having Coronary Artery Disease
- Undergoing coronary artery bypass grafting surgery
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supplement pre and post CABG Supplement pre and post CABG Consumption of the supplement 7 days before and 30 days post surgery Supplement pre CABG Supplement pre CABG Consumption of the supplement 7 days before surgery and placebo 30 days post surgery Placebo Placebo Consumption of placebo 7 days before and 30 days post surgery Supplement post CABG Supplement post CABG Consumption of placebo 7 days before surgery and supplement 30 days post surgery
- Primary Outcome Measures
Name Time Method Hemoglobin A1C 37 days It was measured in 4 steps:
1 week before the operation, Just before the operation, 1 week post operation, 30 days post operationSerum glucose 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 operationInsulin Resistance 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 operationserum insulin 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
- Secondary Outcome Measures
Name Time Method malondialdehyde 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 operationBody Composition changes 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