Coronary Artery DiseasePhase 2ECIRRANCT02184507
Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
A Phase 2 study testing Supplement pre CABG, Supplement post CABG and Supplement pre and post CABG in people with Coronary Artery Disease, run by Mohammad Hassan Eftekhari.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Supplement pre CABG, Supplement post CABG and Supplement pre and post CABG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean age of 30-70 years old, Having Coronary Artery Disease
- Undergoing coronary artery bypass grafting surgery
Who cannot join
- 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%
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Supplement pre CABG, Supplement post CABG, Supplement pre and post CABG, Placebo
- Keywords
- insulin resistance, blood glucose, CABG, oxidative stress
- Medical subject headings
- Coronary Artery Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement pre CABGDietary supplement
One sachet of the supplement was consumed daily for 7 days before surgery.
Supplement post CABGDietary supplement
One sachet of the supplement was consumed daily for 30 days after surgery
Supplement pre and post CABGDietary supplement
One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG
PlaceboDrug
One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG
| Study group | Role | What they receive |
|---|---|---|
| Supplement pre CABG | Experimental | Consumption of the supplement 7 days before surgery and placebo 30 days post surgery Receives: Dietary Supplement: Supplement pre CABG |
| Supplement post CABG | Experimental | Consumption of placebo 7 days before surgery and supplement 30 days post surgery Receives: Dietary Supplement: Supplement post CABG |
| Supplement pre and post CABG | Experimental | Consumption of the supplement 7 days before and 30 days post surgery Receives: Dietary Supplement: Supplement pre and post CABG |
| Placebo | Placebo comparator | Consumption of placebo 7 days before and 30 days post surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 37 days
Secondary outcomes (2)
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
Measured: 37 days
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
Measured: 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Hassan Eftekhari
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Responsible party
- Sponsor-investigator, Mohammad Hassan Eftekhari, Shiraz University of Medical Sciences
- Investigators
- Mohammad Hassan Eftekhari, professor, Study director, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184507
- Sponsor's protocol ID
- 91-6447
- Acronym
- ECIRRA
- Status last verified
- Oct 2014
- First submitted
- 3 Jul 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
- ClinicalTrials.gov ID
- NCT02184507
- Acronym / sponsor ID
- ECIRRA / 91-6447
- Conditions
- Coronary Artery Disease
- Keywords
- insulin resistance, blood glucose, CABG, oxidative stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mohammad Hassan EftekhariUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplement pre CABG | Experimental | Dietary Supplement: Supplement pre CABGConsumption of the supplement 7 days before surgery and placebo 30 days post surgery |
| Supplement post CABG | Experimental | Dietary Supplement: Supplement post CABGConsumption of placebo 7 days before surgery and supplement 30 days post surgery |
| Supplement pre and post CABG | Experimental | Dietary Supplement: Supplement pre and post CABGConsumption of the supplement 7 days before and 30 days post surgery |
| Placebo | Placebo comparator | Drug: PlaceboConsumption of placebo 7 days before and 30 days post surgery |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mean age of 30-70 years old, Having Coronary Artery Disease
- Undergoing coronary artery bypass grafting surgery
Key exclusion criteria (4 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement pre CABGOne sachet of the supplement was consumed daily for 7 days before surgery. | Dietary supplement | Supplement pre CABG |
| Supplement post CABGOne sachet of the supplement was consumed daily for 30 days after surgery | Dietary supplement | Supplement post CABG |
| Supplement pre and post CABGOne sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG | Dietary supplement | Supplement pre and post CABG |
| PlaceboOne sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG | Drug | Placebo |
Primary outcome
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
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
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
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
2 secondary outcomes
Body Composition changes
Time frame: 37 days
malondialdehyde
Time frame: 37 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Hassan Eftekhari, professor study director
Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Supplement pre CABG, Supplement post CABG and Supplement pre and post CABG in people with Coronary Artery Disease, run by Mohammad Hassan Eftekhari.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum glucose (time frame: 37days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.