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Compare the therapeutic effect of metformin, pioglitazone and vitaminE E in patients with non-alcoholic fatty liver disease

Protocol summary

Summary
The present study aim to compare the therapeutic effect of metformin, pioglitazone and vitaminE E in patients with non-alcoholic fatty liver disease. in this study, 93patients with the diagnosis of NAFLD(according to sonographic findings), referred to the Imam-Reza Hospital,Kermanshah during 2009-2011, after obtaining informed consent from participation in the study, were randomly divided into three groups. Then,the three groups received the following treatment regimens for 12weeks: one group received metformin (2gr daily),the second group received pioglitazone(30mg daily)and the third group took vitaminE (800IU daily). Before initiation of the experiment and at the end of treatment course,liver function tests(LFTs), body mass index(BMI), insulin resistance index(HOMA-IR), fasting blood sugar and serum level of insulin were measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010411991N3
Registration date: 2016-01-22, 1394/11/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Azam Sharifi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 1266
Email address
azamsharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the therapeutic effect of metformin, pioglitazone and vitaminE E in patients with non-alcoholic fatty liver disease
Public title
Effect of metformin, pioglitazone and vitaminE E in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with non-alcoholic fatty liver disease according to sonographic findings; Having age between 17 to 50 years; Having negative serology of viral hepatitis; Willingness to participate in the study. Exclusion criteriain: having obvious presentations of hepatic diseases; history of jaundice; taking steroids; alcohol drinking; diabetes; pregnancy; hypothyroidism; renal failure.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 93
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah Univesity of Medical Sciences, Shahid Beheshti Blvd.,Kermanshah.
City
Kermanshah
Postal code
Approval date
2009-05-26, 1388/03/05
Ethics committee reference number
87010

Health conditions studied

1

Description of health condition studied
non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
severity of fatty liver
Timepoint
before and 12 weeks after the interventions
Method of measurement
according to echogenicity of the liver and its comparison with the adjacent kidney, and also comparison with echogenicity of the spleen, and the view of diaphragm and perivascular region of the intrahepatic vessels.

2

Description
serum level of liver function tests (AST, ALT, Alkp)
Timepoint
before and 12 weeks after the interventions
Method of measurement
(IU/l) by diagnostic laboratory kits (Pars Azmoon, Iran) and the auto analyzer (Hitachi 902)

Secondary outcomes

1

Description
body mass index(BMI)
Timepoint
before and 12 weeks after the interventions
Method of measurement
(Kg/m2)

2

Description
insulin resistance index(HOMA-IR)
Timepoint
before and 12 weeks after the interventions
Method of measurement
[fasting glucose (mg/dl) × insulin (µU/ml)]/ 405

3

Description
fasting blood sugar
Timepoint
before and 12 weeks after the interventions
Method of measurement
mg/dlby diagnostic laboratory kits (Pars Azmoon, Iran) and the auto analyzer (Hitachi 902)

4

Description
serum level of insulin
Timepoint
before and 12 weeks after the interventions
Method of measurement
(µu/ml) by Monobind ELISA kit (Monobind, USA)

Intervention groups

1

Description
Intervention group: metformin2 gr daily,orally for12 weeks
Category
Treatment - Drugs

2

Description
Intervention group: Pioglitazone30 mg dialy, orally for12 weeks
Category
Treatment - Drugs

3

Description
Intervention group: vitamin E 800 IU daily, orally for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam-Reza Hospital,Kermanshah
Full name of responsible person
Karoon Shahebrahimi
Street address
Imam-Reza Hospital, Bagh-e Abrisham, Kermansh, Iran.
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti BLV, Kermanshah
City
Kermanshah
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,Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Karoon Shahebrahimi
Position
Faculty of Medicine
Other areas of specialty/work
Street address
Emam Reza hospital, Sorkhelijeh boulevard, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
kshahebrahimi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Karoon Shahebrahimi
Position
Faculty of Medicine
Other areas of specialty/work
Street address
Emam Reza hospital, Sorghelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
kshahebrahimi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Karoon Shahebrahimi
Position
Faculty of Medicine
Other areas of specialty/work
Street address
Emam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
00
Fax
Email
kshahebrahimi@gmail.com
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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