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The effect of Aerobic and Resistance exercise training on liver enzymes, hepatic fat and inflammatory markers in individuals with Non-alcoholic fatty liver disease

Protocol summary

Summary
33 patients with non-alcoholic fatty liver from Clinic Digestive Baqiyatallah hospital will be selected. Inclusion criteria include having more than 5% of fat in the liver, according to the diagnosis through ultrasonography. Patients will be randomly divided into three groups. In the aerobic group, the intervention including 8 weeks of aerobic exercise – in resistance training groups, intervention consists of 8 weeks of resistance training. There will be no intervention in the control group. Before and after the study, lipid profile, hepatic fat, levels of liver enzymes and inflammatory factors are measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701033871N1
Registration date: 2017-01-24, 1395/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Alireza Shamsoddini
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3353
Email address
alirezaot@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aerobic and Resistance exercise training on liver enzymes, hepatic fat and inflammatory markers in individuals with Non-alcoholic fatty liver disease
Public title
ٍEffect of exercise on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for the study, include: Having liver fat than 5% of diagnosed via ultrasound. Exclusion criteria were: (1) have heart disease and kidney (2) patients in order to increase insulin sensitivity (3) patients with type II diabetes.
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
sheikh bahaei Str.
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
6770

Health conditions studied

1

Description of health condition studied
Non Alcoholic Fatty Liver Disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified Nonalcoholic fatty liver disease (NAFLD)

Primary outcomes

1

Description
fat profle
Timepoint
pre
Method of measurement
hemical Kit

2

Description
ALT
Timepoint
pre and 2 month past
Method of measurement
laboratory kit

3

Description
AST
Timepoint
pre and 2 month past
Method of measurement
laboratory kit

4

Description
Hepatic Fat
Timepoint
pre and 2 month past
Method of measurement
laboratory kit

5

Description
Insulin resistance
Timepoint
pre and 2 month past
Method of measurement
laboratory kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention in the trial groups including aerobic and resistance exercise prescription for people with fatty liver.
Category
Other

2

Description
control group receive no treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddinui
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
PhD
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8248 2402
Fax
Email
alirezaot@bmsu.ac.iralirezaot23@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Position
Assistant Professor
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences
City
tehran
Postal code
Phone
+98 21 8248 2402
Fax
Email
alirezaot@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 8248 2402
Fax
+98 88600030
Email
alirezaot2bmsu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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