Comparison of the theraputic effect of pioglitazone and metformin on ultrasound scoring and liver enzymez in potients with non alcoholic fatty liver disease
A comparison of the effect of pioglitazone and VitE 800, metformin and Vit E800 on liver enzymes in two groups of interventions; The effect of concomitant administration of pioglitazone and VitE 800, metformin and Vit E800 on liver ultrasonography in two groups of interventions
Design
Clinical trial of random intervention
Settings and conduct
Patients with fatty liver disease who referred to Vali Asr Hospital
Participants/Inclusion and exclusion criteria
Patients aged 18-65 years old; patients who have been diagnosed with non-alcoholic fatty liver on the basis of ultrasound evidence and tests.
Intervention groups
The first group received pioglitazone mg 30 and VitE 800, and the second group received metformin 1 gr and vitamin E 800 for 6 months.
Main outcome variables
Enzyme Level AST; enzyme Level ALT; Disease grade by ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023083N2
Registration date:2019-09-23, 1398/07/01
Registration timing:registered_while_recruiting
Last update:2019-09-23, 1398/07/01
Update count:0
Registration date
2019-09-23, 1398/07/01
Registrant information
Name
Haleh Rezaee
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 2250
Email address
rezaeeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-18, 1398/02/28
Expected recruitment end date
2019-10-20, 1398/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the theraputic effect of pioglitazone and metformin on ultrasound scoring and liver enzymez in potients with non alcoholic fatty liver disease
Public title
Effect of metformin and pioglitazon in treatment of fatty liver
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18_65 years old
Patients based on ultrasound evidence and testing of non-alcoholic fatty liver
Exclusion criteria:
People under the age of 18
Pregnant and lactating women
People with kidney failure 30> GFR
People with heart failure HF Class 3 and 4
People with liver cirrhosis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool: such as random number table, sealed envelope, statistical software ..
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
Tabriz University of Medical Sciences Ethics Committee
Street address
No.27, Niaaran ave., Abiari blvd., El Goli
City
Tabriz
Province
East Azarbaijan
Postal code
5168659895
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.TBZMED.REC.1398.226
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
Serum Spartate Aminotransferase Level
Timepoint
On arrival and after intervention
Method of measurement
Laboratory methods with Kits
2
Description
Grade sonography
Timepoint
On arrival and after intervention
Method of measurement
Ultrasound machine
3
Description
Serum levels of alanine amino transferase
Timepoint
On arrival and after intervention
Method of measurement
Laboratory methods with Kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the first group received pioglitazone 30 mg for 6 months
Category
Treatment - Drugs
2
Description
Intervention group: second group received metformin 1 gr and VitE 800 for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Vali Asr Hospital
Full name of responsible person
Manochehr Khoshbaten
Street address
No. 27, Irrigation Flake, Villasher, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1376656763
Phone
+98 41 3383 0243
Email
shahrzadshayan@yaho.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Haleh Rezaee
Street address
Faculty of Pharmacy, First floor, Department of Clinical Pharmacy, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3337 2250
Fax
Email
rezaeeha@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Haleh Rezaee
Position
Academic member, Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, First floor, Department of Clinical Pharmacy, University Street, Tabriz
City
Tabriz
Province
Azarbayjan Shargi
Postal code
51664-14766
Phone
+98 41 3337 2250
Fax
Email
rezaeeha@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Haleh Rezaee
Position
PhD of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, First floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Haleh Rezaee
Position
PhD داروسازی بالینی
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, First floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD