Evaluating 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, Shiraz, 2012.
The goal of the present study was to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass 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 will be selected from the non-diabetic patients scheduled for coronary artery bypass grafting surgery. The patients will be allocated to four groups using balanced block randomization method:
group 1: receives the supplement (a 20 gram pack of the supplement daily) 7 days before surgery and placebo (a pack of starch) 30 days post surgery
group 2: receives the placebo 7 days before surgery and supplement 30 days post surgery
group 3: receives the supplement 7 days before and 30 days post surgery
group 4: receives 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 surgery, blood samples will be taken and the levels of hemoglobin A1C, glucose, insulin and malon di aldehyde will be measured. Also, body composition indices were assessed in four times: one week before the surgery, before the onset of the surgery, after the surgery, 1 week after and 4 weeks after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312102480N3
Registration date:2014-01-03, 1392/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Mohammad Hassan Eftekhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
eftekharim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating 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, Shiraz, 2012.
Public title
Evaluating the effect of a new supplement on recovery after open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: male and female patients in the range of 30 to 70 years old, undergoing coronary artery bypass grafting surgery,
exclusion criteria: Diabetes mellitus, Metabolic, hematological, and immune disorders, history of renal problem and CVA, taking antioxidant supplements, emergency operations, ejection fraction < 30%
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2013-02-24, 1391/12/06
Ethics committee reference number
91-6447
Health conditions studied
1
Description of health condition studied
Metabolic, infectious and oxidative complications of coronary artery bypass grafting surgery
ICD-10 code
T82.6, T82
ICD-10 code description
Infection and inflammatory reaction due to cardiac valve prosthesis, Unspecified complication of cardiac and vascular prosthetic device, implant and graft
measured in 5 steps: 1 week before surgery, on the day of surgery before anf after the operation, 1 week after surgery and 1 month after surgery
Method of measurement
spectrophotometric method
2
Description
serum insulin level
Timepoint
measured in 5 steps: 1 week before surgery, on the day of surgery before anf after the operation, 1 week after surgery and 1 month after surgery
Method of measurement
Eliza
3
Description
hemoglobin A1C
Timepoint
measured in 5 steps: 1 week before surgery, on the day of surgery before anf after the operation, 1 week after surgery and 1 month after surgery
Method of measurement
HPLC
4
Description
body composition changes
Timepoint
measured in 4 steps: 1 week before surgery, on the day of surgery, 1 week after surgery and 1 month after surgery
Method of measurement
using Body impedance analyser, skinfold measurement with caliper, and Arm muscle circumference with tape meter
Secondary outcomes
1
Description
lipid peroxidatin level
Timepoint
measured in 5 steps: 1 week before surgery, on the day of surgery before anf after the operation, 1 week after surgery and 1 month after surgery
Method of measurement
TBARS method
Intervention groups
1
Description
group 4: receives placebo (a pack of starch daily) 7 days before and 30 days post surgery
Category
Placebo
2
Description
group 3: receives the supplement (a 20 gram pack of the supplement daily) 7 days before and 30 days post surgery
Category
Treatment - Drugs
3
Description
group 2: receives the placebo (a pack of starch daily) 7 days before surgery and supplement (a 20 gram pack of the supplement daily) 30 days post surgery
Category
Treatment - Drugs
4
Description
group 1: receives the supplement (a 20 gram pack of the supplement daily) 7 days before surgery and placebo (a pack of starch daily) 30 days post surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Heart hospital
Full name of responsible person
Dr. Hojjatollah Rousta
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Street address
Zand BLVD, Shiraz
City
Shiraz
3
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences-Vice Chancellor for Research Affairs
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Nutrition and Food Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
PhD Candidate of Nutrition
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, School of Nutrition and Food Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
marzieh_akbarzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Nutrition and Food Sciences
Full name of responsible person
Dr. Mohammad Hassan Eftekhari
Position
Associate Professor of Nutrition
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, School of Nutrition and Food Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1009
Fax
Email
h_eftekhari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Nutrition and Food Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
PhD Candidate of Nutrition
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, School of Nutrition and Food Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
marzieh_akbarzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)