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

Coronary Artery Disease Clinical Trial

— ECIRRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184507
• Other study ID #: 91-6447
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2014
• Last updated: October 23, 2014
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Insulin Resistance
• Myocardial Ischemia

Intervention

Dietary Supplement:
• Supplement pre CABG
One sachet of the supplement was consumed daily for 7 days before surgery.
• Supplement post CABG
One sachet of the supplement was consumed daily for 30 days after surgery
• Supplement pre and post CABG
One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG

Drug:
• Placebo
One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mohammad Hassan Eftekhari	Shiraz University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No