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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Dietary supplement: Supplement pre CABG; Dietary supplement: Supplement post CABG; Dietary supplement: Supplement pre and post CABG; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mohammad Hassan Eftekhari
• Collaborators: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: CABG; insulin resistance; blood glucose; oxidative stress
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Hyperinsulinism; Coronary Disease; Coronary Artery Disease; Insulin Resistance
• Other Study ID Numbers: 91-6447