Coronary Artery Disease
Conditions
Keywords
insulin resistance, blood glucose, CABG, oxidative stress
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.
Interventions
DIETARY_SUPPLEMENTSupplement pre CABG
One sachet of the supplement was consumed daily for 7 days before surgery.
DIETARY_SUPPLEMENTSupplement post CABG
One sachet of the supplement was consumed daily for 30 days after surgery
DIETARY_SUPPLEMENTSupplement pre and post CABG
One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG
DRUGPlacebo
One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG
Sponsors
Shiraz University of Medical Sciences
Mohammad Hassan Eftekhari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Mean age of 30-70 years old, Having Coronary Artery Disease * Undergoing coronary artery bypass grafting surgery
Exclusion criteria
* 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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum 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 operation |
| serum 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 |
| 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 operation |
| Insulin 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 operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body 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 |
| 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 operation |
Outcome results
None listed