<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02184507</url>
  </required_header>
  <id_info>
    <org_study_id>91-6447</org_study_id>
    <nct_id>NCT02184507</nct_id>
  </id_info>
  <brief_title>Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress</brief_title>
  <acronym>ECIRRA</acronym>
  <official_title>Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohammad Hassan Eftekhari</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shiraz University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aimed to evaluate the effect of a combination of insulin resistance&#xD;
      reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood&#xD;
      glucose and oxidative stress regulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study aimed to evaluate the effect of a combination of insulin resistance&#xD;
      reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood&#xD;
      glucose and oxidative stress regulation. The sample size was estimated to be 92 (23 in each&#xD;
      group). The participants of the study were selected from the non-diabetic patients scheduled&#xD;
      for CABG. The patients were allocated to four groups using balanced block randomization&#xD;
      method:&#xD;
&#xD;
        1. Consumption of the supplement (a 20 gram pack of the supplement daily) 7 days before&#xD;
           surgery and placebo (a pack of starch) 30 days post surgery&#xD;
&#xD;
        2. Consumption of placebo 7 days before surgery and supplement 30 days post surgery&#xD;
&#xD;
        3. Consumption of the supplement 7 days before and 30 days post surgery&#xD;
&#xD;
        4. Consumption of placebo 7 days before and 30 days post surgery One week before, before&#xD;
           the onset of the surgery, after the surgery, 1 week after and 4 weeks after the&#xD;
           operation, blood samples were taken and the levels of hemoglobin A1C, glucose, insulin&#xD;
           and malondialdehyde were measured. Also, body composition indices were assessed in four&#xD;
           times: one week before the surgery, before the onset of the surgery, 1 week after and 4&#xD;
           weeks after the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum glucose</measure>
    <time_frame>37days</time_frame>
    <description>It was measured in 5 steps:&#xD;
1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum insulin</measure>
    <time_frame>37 days</time_frame>
    <description>It was measured in 5 steps:&#xD;
1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin A1C</measure>
    <time_frame>37 days</time_frame>
    <description>It was measured in 4 steps:&#xD;
1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin Resistance</measure>
    <time_frame>37 days</time_frame>
    <description>Calculated by HOMA calculation equation&#xD;
It was calculated in 5 steps:&#xD;
1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition changes</measure>
    <time_frame>37 days</time_frame>
    <description>It was measured in 4 steps:&#xD;
1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>malondialdehyde</measure>
    <time_frame>37 days</time_frame>
    <description>It was measured in 5 steps:&#xD;
1 week before the operation, Just before the operation, After operation, 1 week post operation, 30 days post operation</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Supplement pre CABG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of the supplement 7 days before surgery and placebo 30 days post surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supplement post CABG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of placebo 7 days before surgery and supplement 30 days post surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supplement pre and post CABG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of the supplement 7 days before and 30 days post surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Consumption of placebo 7 days before and 30 days post surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supplement pre CABG</intervention_name>
    <description>One sachet of the supplement was consumed daily for 7 days before surgery.</description>
    <arm_group_label>Supplement pre CABG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supplement post CABG</intervention_name>
    <description>One sachet of the supplement was consumed daily for 30 days after surgery</description>
    <arm_group_label>Supplement post CABG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supplement pre and post CABG</intervention_name>
    <description>One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG</description>
    <arm_group_label>Supplement pre and post CABG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mean age of 30-70 years old, Having Coronary Artery Disease&#xD;
&#xD;
          -  Undergoing coronary artery bypass grafting surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive history of diabetes mellitus, metabolic, hematological, and immune disorders,&#xD;
             renal problem, and cerebrovascular accident&#xD;
&#xD;
          -  Taking antioxidant supplements&#xD;
&#xD;
          -  Cases for emergency operations&#xD;
&#xD;
          -  Ejection Fraction &lt; 30%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Hassan Eftekhari, professor</last_name>
    <role>Study Director</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>October 23, 2014</last_update_submitted>
  <last_update_submitted_qc>October 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mohammad Hassan Eftekhari</investigator_full_name>
    <investigator_title>Professor. PhD</investigator_title>
  </responsible_party>
  <keyword>insulin resistance</keyword>
  <keyword>blood glucose</keyword>
  <keyword>CABG</keyword>
  <keyword>oxidative stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02184507
org study id: 91-6447
nct id: NCT02184507
lead sponsor: 
collaborator: 
has dmc: Yes
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 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Serum glucose
time frame: 37days
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
measure: serum insulin
time frame: 37 days
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
measure: Hemoglobin A1C
time frame: 37 days
description: It was measured in 4 steps:
1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation
measure: Insulin Resistance
time frame: 37 days
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
measure: Body Composition changes
time frame: 37 days
description: It was measured in 4 steps:
1 week before the operation, Just before the operation, 1 week post operation, 30 days post operation
measure: malondialdehyde
time frame: 37 days
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
arm group label: Supplement pre CABG
arm group type: Experimental
description: Consumption of the supplement 7 days before surgery and placebo 30 days post surgery
arm group label: Supplement post CABG
arm group type: Experimental
description: Consumption of placebo 7 days before surgery and supplement 30 days post surgery
arm group label: Supplement pre and post CABG
arm group type: Experimental
description: Consumption of the supplement 7 days before and 30 days post surgery
arm group label: Placebo
arm group type: Placebo Comparator
description: Consumption of placebo 7 days before and 30 days post surgery
intervention type: Dietary Supplement
intervention name: Supplement pre CABG
description: One sachet of the supplement was consumed daily for 7 days before surgery.
arm group label: Supplement pre CABG
intervention type: Dietary Supplement
intervention name: Supplement post CABG
description: One sachet of the supplement was consumed daily for 30 days after surgery
arm group label: Supplement post CABG
intervention type: Dietary Supplement
intervention name: Supplement pre and post CABG
description: One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG
arm group label: Supplement pre and post CABG
intervention type: Drug
intervention name: Placebo
description: One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG
arm group label: Placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mohammad Hassan Eftekhari, professor
role: Study Director
affiliation: Shiraz University of Medical Sciences
responsible party type: Sponsor-Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Mohammad Hassan Eftekhari
investigator title: Professor. PhD
mesh term: Coronary Artery Disease
mesh term: Insulin Resistance