Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Dietary Supplement: Supplement pre CABG
* Dietary Supplement: Supplement post CABG
* Dietary Supplement: Supplement pre and post CABG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement pre CABG<br>Consumption of the supplement 7 days before surgery and placebo 30 days post surgery | Dietary Supplement: Supplement pre CABG<br>* One sachet of the supplement was consumed daily for 7 days before surgery.<br>|
| Experimental: Supplement post CABG<br>Consumption of placebo 7 days before surgery and supplement 30 days post surgery | Dietary Supplement: Supplement post CABG<br>* One sachet of the supplement was consumed daily for 30 days after surgery<br>|
| Experimental: Supplement pre and post CABG<br>Consumption of the supplement 7 days before and 30 days post surgery | Dietary Supplement: Supplement pre and post CABG<br>* One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG<br>|
| Placebo Comparator: Placebo<br>Consumption of placebo 7 days before and 30 days post surgery | Drug: Placebo<br>* One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum glucose | 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 | 37days | 
| serum insulin | 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 | 37 days | 
| Hemoglobin A1C | It was measured in 4 steps: 1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation | 37 days | 
| Insulin Resistance | 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 | 37 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition changes | It was measured in 4 steps: 1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation | 37 days | 
| malondialdehyde | 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 | 37 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood glucose, oxidative stress, insulin resistance, CABG