Studing the effects of Epigallocatechin Gallate supplementation on lipid profile, Insulin resistance, Oxidative stress and inflammatory factors in rs9939609 FTO gene variants in type 2 diabetic patients.
The purpose of this study is to assess the effect of Epigallocatechin Gallate supplementation on lipid profile, Insulin resistance, Oxidative stress and inflammatory factors in rs9939609 FTO gene variants in type 2 diabetic patients. In this randomized, double blind, placebo controlled trial with parallel design,92 patients suffering from type 2 diabetes will be selected among patients referring to diabetes Clinic of golestan Hospital in Ahvaz. Participants will be randomly assigned to intervention or control group (1:1 ratio) based on the blocked randomization method. The intervention and control groups respectively will be received Epigallocatechin Gallate capsules (2 × 150 mg per day) and Nokhodchi flour capsules (2 × 150 mg per day) as placebo for 8 weeks. Inclusion criteria include Patients aged between 20 to 40 years who will be diagnosed with type 2 diabetes. Exclusion criteria for the study will be alcohol consumption; smoking; pregnant and lactating women; injection insulin and Taking anti inflammatory drugs. At the beginning and end of the study different variables of the study include levels of lipid profile, oxidative stress, inflammatory factors and FTO gene variants will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021612949N3
Registration date:2017-04-04, 1396/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-04, 1396/01/15
Registrant information
Name
Meysam Alipour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3050
Email address
alipour.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studing the effects of Epigallocatechin Gallate supplementation on lipid profile, Insulin resistance, Oxidative stress and inflammatory factors in rs9939609 FTO gene variants in type 2 diabetic patients.
Public title
Effect of Epigallocatechin Gallate supplementation on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men or women aged between 20 to 60 years old, Minimum 2 years experience in diabete. Exclusion criteria: Alcohol consumption; smoking; Pregnant and lactating women; injection insulin; Taking anti inflammatory drugs; Using nutrition supplements; Hormone Therapy; Patients with a history of hypothyroidism; renal failure.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
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
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Golestan Ave, Ahvaz, Ahvaz Jundishapur University of Medical Sciences, Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
City
َAhvaz
Postal code
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.AJUMS.REC.1395.548
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus Type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Lipid profile (TG, LDL, HDL, Total cholestrol)
Timepoint
Before and after 8 weeks intervention
Method of measurement
Mg/dl, laboratory kit
2
Description
Serum Total Anti Oxidant Capacity (TAOC)
Timepoint
Before and after 8 weeks intervention
Method of measurement
ELISA
3
Description
High sensitive C reactive protein
Timepoint
Before and after 8 weeks intervention
Method of measurement
ELISA
4
Description
Interleukin 6
Timepoint
Before and after 8 weeks intervention
Method of measurement
ELISA
5
Description
Fasting Blood Sugar (FBS)
Timepoint
Before and after 8 weeks intervention
Method of measurement
Mg/dl, laboratory kit
6
Description
Insulin
Timepoint
Before and after 8 weeks intervention
Method of measurement
ELISA
7
Description
Insulin Resistance (IR)
Timepoint
Before and after 8 weeks intervention
Method of measurement
Based on HOMA IR equation
Secondary outcomes
1
Description
Body Mass Index (BMI)
Timepoint
Before and after 8 weeks intervention
Method of measurement
Weight (kilograms) divided by the square of height (meters)
2
Description
Sistolic and diastolic blood pressure
Timepoint
Before and after 8 weeks intervention
Method of measurement
By mercury sphygmomanometer
Intervention groups
1
Description
All patients will receive 300 mg (2×150mg) epigallocatechin Gallate capsules for 8 weeks.
Category
Treatment - Drugs
2
Description
All patients will receive 300 mg (2×150 mg) placebo capsules (Nokhodchi flour) for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital Clinic
Full name of responsible person
Dr. Mehrnoosh zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Behzad Sharif Makhmalzadeh, Deputy of research development
Street address
Golestan Ave, Ahvaz, Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences Ahvaz
City
Ahvaz
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 of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Meysam Alipour
Position
PhD student of Nutrition
Other areas of specialty/work
Street address
Golestan Ave, Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 3050
Fax
Email
Alipour.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Seyyed Ahmad Hosseini
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Golestan Ave, Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 3050
Fax
Email
Seyedahmadhosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Meysam Alipour
Position
PhD student of Nutrition
Other areas of specialty/work
Street address
Golestan Ave, Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)