Objectives: To determine effects of resveratrol on serum irisin and adiponectin in patients with type 2 diabetes. Design: Randomized double-blind placebo-controlled clinical trial. Participants: Patients with type 2 diabetes with BMI more than 25. Setting and conduct: Fifty five eligible patients with type 2 diabetes will be referred from Institute of Endocrinology and Metabolism, Firoozgar Hospital. They will be randomly assigned into two groups to receive daily either 240 mg resveratrol or placebo for 8 weeks. 10 cc fasting venous blood samples will be obtained at the beginning and the end of intervention and serum irisin and adiponectin will be measured by ELISA. In order to control confounding factors, height, weight, body fat and muscle percent, food intakes, physical activity, age, sex, FBS, insulin, HbA1c and medications will be assessed before and after intervention. Intervention: 240 mg resveratrol or placebo. Main outcome measures: serum irisin and adiponectin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601022394N19
Registration date:2016-07-24, 1395/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-24, 1395/05/03
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of resveratrol supplementation on serum irisin and adiponectin in patients with type 2 diabetes
Public title
Effect of resveratrol on serum irisin and adiponectin in patients With type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of type 2 Diabetes for at least 2 years; willing to participate; BMI more than 25; age between 45 to 70 years old. Exclusion criteria: Significant diseases including cardiovascular, renal and liver diseases, or cancer; pregnancy; lactation; insulin use; weight and BMI change; consumption of nutritional supplements within the past 8 weeks.
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Ethic committe of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmet Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-09-25, 1394/07/03
Ethics committee reference number
IR.IUMS.REC.1394.26168
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
non-insulin-dependent-diabetes-mellitus
Primary outcomes
1
Description
Irisin
Timepoint
At baseline and after 8 weeks
Method of measurement
ELISA
2
Description
Adiponectin
Timepoint
At beaseline and after 8 weeks
Method of measurement
ELISA
Secondary outcomes
1
Description
Fasting Blood Sugar (FBS)
Timepoint
At baseline and after 8 weeks
Method of measurement
Biochemical assessment
2
Description
HbA1C
Timepoint
At baseline and after 8 weeks
Method of measurement
Biochemical assessment
3
Description
Insulin
Timepoint
At baseline and after 8 weeks
Method of measurement
ELISA
Intervention groups
1
Description
Resveratrol- 240 mg/day with lunch for 8 weeks
Category
Treatment - Other
2
Description
Placebo- 240 mg/day with lunch for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Institute of Endocrinology and Metabolism, Firouzgar Hospital, Iran University of Medical Sciences
Full name of responsible person
Zahra Khajehpour
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Moosavi
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Department of Nutrition, School of Public Health, Iran University of Medical Sciences.
Full name of responsible person
Zahra Khajehpour
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8862 2806
Fax
Email
zahra.khajehpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Nutrition, School of Public Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shima Jazayeri
Position
MD, PhD.
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
jazayeri.sh@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Nutrition, School of public Health, Iran University of Medical Sciences
Full name of responsible person
Zahra Khajehpour
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran.
City
Postal code
Phone
00
Fax
Email
zahra.khajehpour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)