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Comparison of therapeutic effects of metformin, pioglitazone and vitamin E on nonalcoholic fatty liver disease patients

Protocol summary

Summary
Aim: comparison of the therapeutic effects of metformin, pioglitazone and vitamin E in patients with Non-alcoholic fatty liver disease (NAFLD). Methods: In this clinical trial, 93 patients in Imam Reza Hospital, Kermanshah, diagnosed with NAFLD ( finding on ultrasonography) were randomly divided into three groups. Patients randomized into study groups by 1:1 ratio method using a computer-generated random numbers‎. Inclusion criteria: Age above 18 year and Non-alcoholic fatty liver disease alone with negative hepatitis serology. Exclusion criteria: clinical manifestation of liver disease, icter, steroid and alcohol use, diabetes, pregnancy, hypothyroidism, renal failure.Each group received group A: 2 gr/daily metformin, group B: 30 mg/daily pioglitazone, group C, 800 IU/daily vitamin E for 12 weeks. Liver function tests, body mass index, hemostatic assessment model, blood glucose and insulin levels were measured before and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071313069N2
Registration date: 2013-09-22, 1392/06/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Mohammad Rasoul Ghadami
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
mrghadami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2007-06-06, 1386/03/16
Expected recruitment end date
2009-11-07, 1388/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of metformin, pioglitazone and vitamin E on nonalcoholic fatty liver disease patients
Public title
Comparison of metformin, pioglitazone and vitamin E on nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age above 18 year and Non-alcoholic fatty liver disease alone with negative hepatitis serology Exclusion criteria: clinical manifestation of liver disease, icter, steroid and alcohol use, diabetes, pregnancy, hypothyroidism, renal failure.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients randomized into study groups by 1:1 ratio method using a computer-generated random numbers‎. Physician who evaluates patients is blind to treatment interventions.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shaihid Beheshti Blvd. Build no. 2
City
Kermanshah
Postal code
Approval date
2013-02-15, 1391/11/27
Ethics committee reference number
پ/7/420/53475

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
Liver enzymes, Blood sugar, Insulin
Timepoint
Before and 12 weeks after treatment
Method of measurement
Laboratory assessment (ELISA)

Secondary outcomes

1

Description
Liver echo pattern
Timepoint
Before and 12 weeks after treatment
Method of measurement
Sonographic assessment

Intervention groups

1

Description
Group A:Tablet metformine 2gr/day orally (two 500 mg tablets q 12h) for 12 weeks
Category
Treatment - Drugs

2

Description
Group B: Tablet pioglitazone 30 mg/day orally ( one 15 mg tablet q 12h) for 12 weeks
Category
Treatment - Drugs

3

Description
Group C: Tablet vitamin E 800 IU/day orally (One 400 IU tablet q 12h) for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Street address
Sorkheh lizheh
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
Dr. Farid Najafi
Street address
Build No. 2 of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
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
Dr. Mohammad Rasoul Ghadami
Position
General physician
Other areas of specialty/work
Street address
Imam Reza Hospital, Sorkheh lizheh
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
mr_ghadami@yahoo.com mrghadami@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rasoul Ghadami
Position
General physician
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
mr_ghadami@yahoo.com mrghadami@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Mohammad Rasoul Ghadami
Position
General physician
Other areas of specialty/work
Street address
Imam Reza Hospital, Sorkheh lizheh
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
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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