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

Mohammad Hassan Eftekhari

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Dietary Supplement: Supplement pre CABG; Drug: Placebo; Dietary Supplement: Supplement pre and post CABG; Dietary Supplement: Supplement post CABG

Study type: Interventional

Funder types: Other

Identifiers

NCT02184507

91-6447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 4 patient groups, including a placebo group

Supplement pre CABG

Experimental group

Description:

Consumption of the supplement 7 days before surgery and placebo 30 days post surgery

Treatment:

Dietary Supplement: Supplement pre CABG

Supplement post CABG

Experimental group

Description:

Consumption of placebo 7 days before surgery and supplement 30 days post surgery

Treatment:

Dietary Supplement: Supplement post CABG

Supplement pre and post CABG

Experimental group

Description:

Consumption of the supplement 7 days before and 30 days post surgery

Treatment:

Dietary Supplement: Supplement pre and post CABG

Placebo

Placebo Comparator group

Description:

Consumption of placebo 7 days before and 30 days post surgery

Treatment:

Drug: Placebo