NCT02184507

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_2 coronary-artery-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

July 3, 2014

Last Update Submit

October 23, 2014

Conditions

Coronary Artery Disease

Keywords

insulin resistanceblood glucoseCABGoxidative stress

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (2)

  • Body Composition changes

    37 days

  • malondialdehyde

    37 days

Study Arms (4)

Supplement pre CABG

EXPERIMENTAL

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

Dietary Supplement: Supplement pre CABG

Supplement post CABG

EXPERIMENTAL

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

Dietary Supplement: Supplement post CABG

Supplement pre and post CABG

EXPERIMENTAL

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

Dietary Supplement: Supplement pre and post CABG

Placebo

PLACEBO COMPARATOR

Consumption of placebo 7 days before and 30 days post surgery

Drug: Placebo

Interventions

Supplement pre CABGDIETARY_SUPPLEMENT

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

Supplement pre CABG
Supplement post CABGDIETARY_SUPPLEMENT

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

Supplement post CABG
Supplement pre and post CABGDIETARY_SUPPLEMENT

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

Supplement pre and post CABG
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mean age of 30-70 years old, Having Coronary Artery Disease
  • Undergoing coronary artery bypass grafting surgery

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseInsulin Resistance

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mohammad Hassan Eftekhari, professor

    Shiraz University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor. PhD

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

July 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10