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

NCT ID: NCT02184507

Last Updated: 2014-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Supplement pre CABG

Consumption of the supplement 7 days before surgery and placebo 30 days post surgery

Group Type EXPERIMENTAL

Supplement pre CABG

Intervention Type DIETARY_SUPPLEMENT

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

Supplement post CABG

Consumption of placebo 7 days before surgery and supplement 30 days post surgery

Group Type EXPERIMENTAL

Supplement post CABG

Intervention Type DIETARY_SUPPLEMENT

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

Supplement pre and post CABG

Consumption of the supplement 7 days before and 30 days post surgery

Group Type EXPERIMENTAL

Supplement pre and post CABG

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Consumption of placebo 7 days before and 30 days post surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Supplement pre CABG

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

Intervention Type DIETARY_SUPPLEMENT

Supplement post CABG

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role collaborator

Mohammad Hassan Eftekhari

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Hassan Eftekhari

Professor. PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohammad Hassan Eftekhari, professor

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences

Other Identifiers

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91-6447

Identifier Type: -

Identifier Source: org_study_id

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