Protocol summary
-
Study aim
-
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 outpatient Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
-
Participants/Inclusion and exclusion criteria
-
patients with T2DM, aged 40-85 years old with proven 2- and 3-vessel CHD will be included in this study. Exclusion criteria: consuming resveratrol three months prior to the intervention, taking antioxidant and/or anti-inflammatory supplements such as vitamin E and vitamin C, having an acute myocardial infarction or cardiac surgery in the past three months, or having renal or hepatic failure
-
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 resistance (primary outcomes) and biomarkers of inflammation and oxidative stress factors, FPG, insulin, QUICKI, serum lipids, IL-1, PPAR-γ, TNF-α, TGF-β, SIRT1 (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:
2019-09-04, 1398/06/13
Update count:
1
-
Registration date
-
2018-12-05, 1397/09/14
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-08-16, 1397/05/25
-
Expected recruitment end date
-
2018-09-16, 1397/06/25
-
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:
patients with T2DM, aged 40-85 years old with proven 2- and 3-vessel CHD
Exclusion criteria:
Consuming resveratrol three months prior to the intervention
Taking antioxidant and/or anti-inflammatory supplements such as vitamin E and vitamin C
Having an acute myocardial infarction or cardiac surgery in the past three months
Having renal or hepatic failure
-
Age
-
From 40 years old to 85 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 balanced randomization 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
-
Ethics committees
1
-
Ethics committee
-
-
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
5
-
Description
-
Gene expression of sirtuin1
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Real Time PCR
6
-
Description
-
Gene expression of interleukin-1(IL-1)
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Real Time PCR
7
-
Description
-
Gene expression of tumor necrosis factor alpha (TNF-α)
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Real Time PCR
8
-
Description
-
Gene expression of transforming growth factor beta (TGF-β)
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Real Time PCR
9
-
Description
-
Gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ)
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Real Time PCR
10
-
Description
-
Fasting plasma glucose
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Enzymatic kit
11
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Elisa kit
12
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Enzymatic kit
13
-
Description
-
VLDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Enzymatic kit
14
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Enzymatic kit
15
-
Description
-
LDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Enzymatic kit
16
-
Description
-
HDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Enzymatic kit
17
-
Description
-
Quantitative insulin sensitivity check index(QUICKI)
-
Timepoint
-
At the beginning of the study and after 4 weeks of intervention
-
Method of measurement
-
Calculation using standard formula
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
1
-
Sponsor
-
-
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
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