Skip to main content
OpenTrials
Completed

NCT Number: NCT02184507

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Supplement pre CABG

Dietary Supplement

One sachet of the supplement was consumed daily for 7 days before surgery.

Supplement post CABG

Dietary Supplement

One sachet of the supplement was consumed daily for 30 days after surgery

Supplement pre and post CABG

Dietary Supplement

One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG

Placebo

Drug

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

Primary outcomes

  1. Serum glucose

    Time frame: 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

  2. serum insulin

    Time frame: 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

  3. Hemoglobin A1C

    Time frame: 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

  4. Insulin Resistance

    Time frame: 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 outcomes

  1. Body Composition changes

    Time frame: 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

  2. malondialdehyde

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mohammad Hassan Eftekhari

Other

Collaborators

  • Shiraz University of Medical Sciences

Registry information

Acronym: ECIRRA

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2014
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.