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Compare of orlistat and metformin in the treatment of fatty liver disease in non-diabetic patients

Protocol summary

Summary
Due to the high sensitivity of the disease and few studies in this field, the object of this study was to compare the effect of Orlistat and Metformin in the treatment of fatty liver disease in patients without diabetes mellitus. The method: This study was designed for 12 to 15 weeks and clinical trial. 100 non-diabetic patients with fatty liver disease were referred to Imam Khomeini hospital clinics, are selected. Patients are divided into 2 groups A and B. Group A are patients that 50 people will be prescribed Metformin and that 50 people are in Group B will be prescribed Orlistat. Vitamins or other nutrients will not be prescribed. Considered in all patients (demographic, etc.) Will respond. Blood samples will be collected before and after treatment. Also patients before and after treatment will be examined by ultrasound sonographer. Ultrasound study, each patient before and after each patient by a sonographer and the tests will be carried out by a laboratory center. Eventually the two groups in terms of improving liver function checked. The two groups were compared in terms of better grade. Inclusion criteria for the study: Having Nonalcoholic fatty liver disease, the absence of diabetes mellitus, Fatty liver grade 2 and above, not having severe systemic disease, Lack of viral and autoimmune hepatitis, Lack of thyroid disease, do not have hyper triglyceridemia. Exclusion criteria: Having severe systemic disease, having viral hepatitis and autoimmune, having thyroid disease, Hyper triglyceridemia

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016031827097N1
Registration date: 2016-06-05, 1395/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-05, 1395/03/16
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardebil University of Medical Sciences
Expected recruitment start date
2016-03-05, 1394/12/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare of orlistat and metformin in the treatment of fatty liver disease in non-diabetic patients
Public title
The effect of orlistat and metformin in the treatment of fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: Having Nonalcoholic fatty liver disease, the absence of diabetes mellitus, Fatty liver grade 2 and above, not having severe systemic disease, Lack of viral and autoimmune hepatitis, Lack of thyroid disease, do not have hyper triglyceridemia and Exclusion criteria: Having severe systemic disease, having viral hepatitis and autoimmune, having thyroid disease, Hyper triglyceridemia)
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
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
Ardebil University of Medical Sciences
Street address
Ardebil University of Medical Sciences, University street, Ardabil, Iran
City
Ardebil
Postal code
Approval date
2016-02-24, 1394/12/05
Ethics committee reference number
IR.ARUMS.REC.1394.87

Health conditions studied

1

Description of health condition studied
Fatty liver
ICD-10 code
(K75.8)
ICD-10 code description
nonalcoholic steatohepatitis

Primary outcomes

1

Description
Triglyceride of blood
Timepoint
Befor and after the study
Method of measurement
Milligrams per deciliter

Secondary outcomes

empty

Intervention groups

1

Description
Tablet Metformin 1000mg once in a day for 3 mounths
Category
Treatment - Drugs

2

Description
Tablet Orlistat 120mg once in a day for 3 mounths
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomini Hospital
Full name of responsible person
Dr babak shirinzadeh
Street address
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr shahram habibzadeh
Street address
Ardebil University of Medical Sciences, University street, Ardabil, Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardebil 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
Ardebil University of Medical Sciences
Full name of responsible person
Dr Iranparvar
Position
Subspecial
Other areas of specialty/work
Street address
Imam khomini hospital, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 914 415 0700
Fax
Email
m.iranparvar@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Yazdanbod
Position
Subspecial
Other areas of specialty/work
Street address
Imam Khomini Hospital, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 910 407 0448
Fax
Email
A.yazdanbod@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr babak shirinzadeh
Position
Internal Medicine Assistant
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, University street, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 914 151 3568
Fax
Email
naghizadeh73@yahoo.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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