The Effect of Eight Weeks Endurance Training and Low Calorie Diet on Serum Levels of Some Biomarkers Related to Endothelial Dysfunction-Atherosclerosis and Carotid Artery Carotid Intima Media Thickness in Men Involved Non-alcoholic Fatty Liver Disease
The aim of this study was to investigate the effect of eight weeks endurance training and low calorie diet on some serum levels of biomarkers related to endothelial dysfunction-atherosclerosis and carotid intima media thickness in male patients involved nonalcoholic fatty liver disease. For this purpose, 32 Men involved non-alcoholic fatty liver disease selected and randomly will be divided into four groups, Endurance training (8 weeks of endurance training), either low calorie diet and endurance training groups (8 weeks of endurance training and diet), low-calorie diet group (8 weeks diet) and control group (without endurance training and diet). Before and after 8 weeks of intervention, carotid intima media thickness of all participants and serum levels of Lipid Profile, Homocysteine, hs-CRP, Visfatin, Pentraxin-3, Resistin and Chemerin of them will assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102330450N1
Registration date:2017-03-03, 1395/12/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-03, 1395/12/13
Registrant information
Name
Asghar Mahmoudi
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 41 5266 2206
Email address
a.mahmoodi@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-01-09, 1395/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eight Weeks Endurance Training and Low Calorie Diet on Serum Levels of Some Biomarkers Related to Endothelial Dysfunction-Atherosclerosis and Carotid Artery Carotid Intima Media Thickness in Men Involved Non-alcoholic Fatty Liver Disease
Public title
The Effect of Exercise and Diet on Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men with nonalcoholic fatty liver grade 2 and 3 detected by ultrasound; Do not use alcohol; Aged 18 to 45 years; The ability of doing physical exercise.
Exclusion criteria: Use of drug-induced hepatic steatosis such as prednisone, corticosterone, amiodarone and ...; uses more from 20 grams of alcohol daily; Hepatitis B and C.
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil university of medical sciences
Street address
Ardabil- Kausar Town- Daneshgah Square- Ardabil University of Medical Sciences
City
Ardabil
Postal code
5618985991
Approval date
2017-01-04, 1395/10/15
Ethics committee reference number
IR.ARUMS.REC.1395.93
Health conditions studied
1
Description of health condition studied
Nonalcoholic Fatty Liver Disease
ICD-10 code
k76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Visfatin
Timepoint
Before & aeter 8 weeks modality
Method of measurement
ELISA
2
Description
Resistin
Timepoint
Before & aeter 8 weeks modality
Method of measurement
ELISA
3
Description
hs-CRP
Timepoint
Before & aeter 8 weeks modality
Method of measurement
ELISA
4
Description
Lipid Profile
Timepoint
Before & aeter 8 weeks modality
Method of measurement
LDL,HDL.Chol,TG,VLDL
5
Description
Homocysteine
Timepoint
Before & aeter 8 weeks modality
Method of measurement
ELISA
6
Description
Chemerin
Timepoint
Before & aeter 8 weeks modality
Method of measurement
ELISA
7
Description
Carotid Intima Media Thickness
Timepoint
Before and aete 8 weeks modality
Method of measurement
Ultrasound
8
Description
Pentraxin-3
Timepoint
Before and aete 8 weeks
Method of measurement
ELISA
Secondary outcomes
1
Description
ALT
Timepoint
Before & after 8 weeks
Method of measurement
ELISA
2
Description
AST
Timepoint
Before & after 8 weeks
Method of measurement
ELISA
3
Description
Body Mass Index
Timepoint
Before & after 8 weeks
Method of measurement
Weight and Height
4
Description
Malondialdehyde
Timepoint
Before & after 8 weeks
Method of measurement
ELISA
5
Description
Superoxide Dismutase
Timepoint
Before & after 8 weeks
Method of measurement
ELISA
6
Description
Glutathione Peroxidase
Timepoint
Before & after 8 weeks
Method of measurement
ELISA
7
Description
Total Antioxidant Capacity
Timepoint
Before & after 8 weeks
Method of measurement
ELISA
Intervention groups
1
Description
Endurance Exercise
Category
Lifestyle
2
Description
Endurance Exercise with Diet
Category
Lifestyle
3
Description
Diet
Category
Lifestyle
4
Description
Control Gruop, Without Lifestyle Modality
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Imam Khomeini Hospital
Full name of responsible person
Manuchehr Iranparvar
Street address
Ardabil Imam Khomeini Hospital
City
Ardabil
2
Recruitment center
Name of recruitment center
Ardabil Imam Khomeini Hospital
Full name of responsible person
Hassan Anari
Street address
Ardabil Imam Khomeini Hospital
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Marefat Siahkohian
Street address
Ardabil-Daneshgah street- University of Mohaghegh Ardabili
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Mohaghegh Ardabili
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
University of Mohaghegh Ardabili
Full name of responsible person
Asghar Mahmoudi
Position
Ph.D. Candidate
Other areas of specialty/work
Street address
Ardabil- University of Mohaghegh Ardabili
City
Ardabil
Postal code
Phone
+98 45 3352 3164
Fax
Email
asgharmahmoodi64@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Asghar Mahmoudi
Position
PH.D Candidate
Other areas of specialty/work
Street address
Ardabil-University of Mohaghegh Ardabili
City
Ardabil
Postal code
Phone
+98 45 3352 3164
Fax
Email
a.mahmoodi@uma.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Asghar Mahmoudi
Position
Ph.D. Candidate
Other areas of specialty/work
Street address
Ardabil-University of Mohaghegh Ardabili
City
Ardabil
Postal code
Phone
+45 33 52 31 64
Fax
Email
a.mahmoudi@uma.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)