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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Supplement pre CABG
Supplement post CABG
Supplement pre and post CABG
Placebo
Sponsored by
Mohammad Hassan Eftekhari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring insulin resistance, blood glucose, CABG, oxidative stress

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Supplement pre CABG

    Supplement post CABG

    Supplement pre and post CABG

    Placebo

    Arm Description

    Consumption of the supplement 7 days before surgery and placebo 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

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    July 3, 2014
    Last Updated
    October 23, 2014
    Sponsor
    Mohammad Hassan Eftekhari
    Collaborators
    Shiraz University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02184507
    Brief Title
    Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
    Acronym
    ECIRRA
    Official Title
    Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mohammad Hassan Eftekhari
    Collaborators
    Shiraz University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    insulin resistance, blood glucose, CABG, oxidative stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supplement pre CABG
    Arm Type
    Experimental
    Arm Description
    Consumption of the supplement 7 days before surgery and placebo 30 days post surgery
    Arm Title
    Supplement post CABG
    Arm Type
    Experimental
    Arm Description
    Consumption of placebo 7 days before surgery and supplement 30 days post surgery
    Arm Title
    Supplement pre and post CABG
    Arm Type
    Experimental
    Arm Description
    Consumption of the supplement 7 days before and 30 days post surgery
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Consumption of placebo 7 days before and 30 days post surgery
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Supplement pre CABG
    Intervention Description
    One sachet of the supplement was consumed daily for 7 days before surgery.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Supplement post CABG
    Intervention Description
    One sachet of the supplement was consumed daily for 30 days after surgery
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Supplement pre and post CABG
    Intervention Description
    One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG
    Primary Outcome Measure Information:
    Title
    Serum glucose
    Description
    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
    Time Frame
    37days
    Title
    serum insulin
    Description
    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
    Time Frame
    37 days
    Title
    Hemoglobin A1C
    Description
    It was measured in 4 steps: 1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation
    Time Frame
    37 days
    Title
    Insulin Resistance
    Description
    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
    Time Frame
    37 days
    Secondary Outcome Measure Information:
    Title
    Body Composition changes
    Description
    It was measured in 4 steps: 1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation
    Time Frame
    37 days
    Title
    malondialdehyde
    Description
    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
    Time Frame
    37 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Hassan Eftekhari, professor
    Organizational Affiliation
    Shiraz University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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