The effect of Resveratrol supplement on metabolic profiles and genes expression of Sirtuin-1، TNF-α، TGF-β، IL-1، PPARγ in diabetetic coronary artery disease patients
The aim of this study is to determine the effects of Resveratrol supplementation on metabolic profilesand and genes expression of Sirtuin-1 ،TNF-α، TGF-β، IL-1، PPARγ in diabetetic coronary artery disease patients
Design
Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: Among patients with CHD referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Individuals aged 40-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate
Intervention groups
Patients will be assigned into two groups to receive Resveratrol supplement (n=30) or placebo (n=30). Resveratrol and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 4 weeks after the intervention. At the beginning and end of the intervention: 4 weeks.
Main outcome variables
Insulin metabolism parameters (primary outcomes) and biomarkers of inflammation and oxidative stress factors (secondry outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181029041490N1
Registration date:2018-12-05, 1397/09/14
Registration timing:retrospective
Last update:2018-12-05, 1397/09/14
Update count:1
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Asma Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 8702
Email address
hosseini-as@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-16, 1397/05/25
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Resveratrol supplement on metabolic profiles and genes expression of Sirtuin-1، TNF-α، TGF-β، IL-1، PPARγ in diabetetic coronary artery disease patients
Public title
Effect of supplementation in treatment of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged 40-75 years; diagnosed with type 2 diabetes and CHD
Not having history of inflammatory or autoimmune diseases, malignancies, thyroid
Exclusion criteria:
Unwillingness to cooperate
Current acute infection or inflammatory disease like rheumatoid arthritis
Diagnosis of renal failure
Diagnosis of Chronic Liver Disease
Age
From 40 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
randomization will be performed with simple method and random numbers generated by computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, researchers, data collectors, evaluators and data analyzers are not aware of which group is placebo or supplemented.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-08-13, 1397/05/22
Ethics committee reference number
IR.Kaums.MEDNT.REC.1397.41
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
hs-CRP
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Elisa kit
2
Description
Total antioxidant
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
At the beginning of the study and after 4 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Resveratrol supplements, 500mg, daily, for 4 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo, daily, for 4 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8713743444
Phone
+98 31 5545 0031
Email
naghavihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamreza Namazi
Position
Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
namazimajid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamreza Namazi
Position
Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
namazimajid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamreza Namazi
Position
Academic staff member of the Department of Clinical Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
namazimajid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available