Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ration in T2DM patients.
Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ration in T2DM patients.
Design
The present study will be conducted on type 2 diabetes patients who have been diagnosed with diabetes based on WHO criteria and approved by the endocrinologist. Randomization will be conducted based on stratified blocked randomization method using two parameters of gender and age. Eventually, 72 patients will be introduced into the group receiving resveratrol (at a dose of 1000 mg) and the placebo (methyl cellulose) recipients by stratification using random number table.
Settings and conduct
The present study will be conducted in a double blind randomized controlled trial. Participants and researchers will not be aware of the supplemental and placebo content.The duration of the intervention will be 8 weeks. After giving a complete explanation about how the study is done, blood sampling and obtaining informed consent form, a demographic questionnaire will be completed at the beginning of the study. Two 3-day food record form is delivered to the patients and is required to write their food items, of the first and the last week of the study. (2 weekdays and 1 weekend). The level of physical activity will be measured using the MET questionnaire once at the beginning of the intervention and once at the end of the intervention. Anthropometric measurements including height, weight, waist circumference, hip circumference and body composition will be estimated at the beginning and end of the study. After 12 hours fasting, 10 ml of venous blood sample will be collected at the beginning and end of the intervention. Biochemical analyses will be including lipid profile (total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol) serum fasting blood glucose, fasting insulin and HbA1c, which will be measured by the standard methods. The gene expression of p16, p53, p21 and PPARα will be investigated at mRNA level using the Real Time PCR method. Commercially available ELISA kits will be used to measure serum sCD163 and sTWEAK.
Participants/Inclusion and exclusion criteria
Male and female with type 2 diabetes mellitus, aged 30-60 years with a body mass index of 24-30 kg/m2 will be included in the study. People who have other illnesses, have antioxidant supplements or alcoholic beverages, have uncontrolled blood glucose or take insulin, and pregnant or lactating women will not be included in the study.
Intervention groups
The intervention and control group will be received capsules containing resveratrol (at a dose of 1000 mg/day) and methyl cellulose (at a dose of 1000 mg / day) respectively, for 8 weeks.
Main outcome variables
Expression values of p16, p21, p53 and PPARα genes; serum levels of sCD163; serum levels of sTWEAK.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171118037528N1
Registration date:2017-12-29, 1396/10/08
Registration timing:prospective
Last update:2017-12-29, 1396/10/08
Update count:4
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
shima abdollahi
Name of organization / entity
shahid sadoughi university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 353820910014
Email address
sh-abdollahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
shahid sadoughi University of Medical Sciences
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ration in T2DM patients.
Public title
Effect of resveratrolon vascular function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female subjects with established T2DM, who have been diagnosed for at least three months
who have body mass index between 24-30 kgm2,
and aged 30-60 years,
Exclusion criteria:
clinical diagnosis of any liver, kidney, cancer and Alzheimer's diseases
insulin therapy;
HbA1c≥ 8%
consumption of any antioxidant supplements in the last six months
history of allergic reaction to grapes;
consumption of anticoagulants, fibrates and aspirin
drinking red wine and alcohol
history of myocardial infraction
presence of stent or battery in the heart
gastrointestinal ulcer
pregnancy or lactation;
follow the unusual diet until one month before the study;
unwillingness to participation in study
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified blocked randomization method will be used based on sex (male and female) and age (30-45 years and 45-60 years). To assign individuals to the intervention and control groups, a random number table will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebos will be provided in the same appearance and shape and they will be packed in the same bottles, and the only difference will be the letters (A and B) on the bottles. Labels will be affixed to the bottles by someone who is not related to the study. Each bottle contains 120 capsules (for one-month usage). Participants and administrators will be unaware about the contents in the bottles.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shahid sadoughi university of medical science
Street address
Yazd, Safayeh, Alam Square, shahid sadoughi university of medical science
City
yazd
Postal code
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
ir.ssu.sph.rec.1396.120
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Proxisome proliferatore activated receptor alpha
Timepoint
Before and after intervention
Method of measurement
Gene expression
2
Description
p53 gene
Timepoint
Before and after intervention
Method of measurement
Gene expression
3
Description
p21 gene
Timepoint
Before and after intervention
Method of measurement
Gene expression
4
Description
p16 gene
Timepoint
Before and after intervention
Method of measurement
Gene expression
5
Description
Soluble Cluster of Differentiation 163
Timepoint
Before and after intervention
Method of measurement
Serum concentration using kit and The enzyme-linked immunosorbent assay method
6
Description
TNF-related weak inducer of apoptosis
Timepoint
Before and after intervention
Method of measurement
Serum concentration using kit and The enzyme-linked immunosorbent assay method
Secondary outcomes
1
Description
Total Triglyceride
Timepoint
Before and after intervention
Method of measurement
Turbidometry
2
Description
Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Turbidometry
3
Description
High density lipoprotein Cholesterol
Timepoint
Before and after intervention
Method of measurement
Turbidometry
4
Description
Low density lipoprotein Cholesterol
Timepoint
Before and after intervention
Method of measurement
Turbidometry
5
Description
Fasting blood glucose
Timepoint
Before and after intervention
Method of measurement
Turbidometry
6
Description
Glycated hemoglobin
Timepoint
Before and after intervention
Method of measurement
Enzymatic kit
7
Description
Fasting insulin
Timepoint
Before and after intervention
Method of measurement
The enzyme-linked immunosorbent assay
Intervention groups
1
Description
Patients in the intervention group will receive two capsules of 500 milligrams of resveratrol per day in 8 weeks.
Category
Prevention
2
Description
Patients in the control group will receive two capsules of 500 milligrams of methyl cellulose per day in 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center and Clinics
Full name of responsible person
Street address
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid sadoughi university of medical science
Full name of responsible person
Research Associate, School of Public Health
Street address
Yazd - Alam Square - shohadaye gomnam Blvd - Campus of Shahid Sadoughi University of Medical Sciences Yazd - School of Public Health
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
ُShima Abdollahi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Safaeiye Ave., Alam Square., Shahid Sadoughi University of Medical Science
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2241
Fax
Email
sh-abdollahi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hassan Mozaffari Khosravi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2241
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shima Abdollahi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 13., Moein Ave., Pounak
City
Tehran
Province
Tehran
Postal code
8915173160
Phone
+98 21 4482 9552
Fax
Email
sh.abd6864@yahoo.com
Web page address
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I have not yet decided on this.
When the data will become available and for how long
I have not yet decided on this.
To whom data/document is available
I have not yet decided on this.
Under which criteria data/document could be used
I have not yet decided on this.
From where data/document is obtainable
I have not yet decided on this.
What processes are involved for a request to access data/document