Study of the efficacy of coadministration of Pioglitazone and Vitamin E compared to coadministration Metformin and Ursodeoxycholic acid (UDCA) on ultrasound scoring and liver enzymes in patients with non-alcoholic fatty liver
The effect of concomitant administration of Pioglitazone and Vitamin E in comparison with the simultaneous administration of Metformin and Ursodeoxycholic acid in improving patients with non-alcoholic fatty liver
Design
Block randomized, Clinical trial, phase 3
Settings and conduct
This study will be conducted on patients with non-alcoholic fatty liver who are referred to the Center for Applied Scientific Research. A group of patients will receive Pioglitazone 15 mg plus Vitamin E 800 IU and another Metformin plus UDCA for 6 months on an daily basis. At the start of the study, 3 months after and at the end of the study blood samples will be taken from all subjects to measure the level of liver enzymes. Also at this intervals, patients will be screened by ultrasound for fatty liver gradients.
Measuring the level of liver enzymes in the Danesh lab and performing ultrasound in the Tabesh imaging center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-65 years; patients who have been diagnosed with non-alcohol fatty liver based on ultrasound and tests; People with diabetes controlled (HbA1C below 8%)
Exclusion criteria: People with heart failure (HF) classes 3 and 4; People with renal insufficiency (GFR <30); People with bladder cancer; patients with osteoporosis; pregnant and lactating women
Intervention groups
Intervention group 1: Pioglitazone plus vitamin E
Intervention group 2: Metformin plus Ursodeoxycholic acid
Main outcome variables
Liver Enzymes (AST; ALT)
Ultrasound grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N1
Registration date:2018-11-22, 1397/09/01
Registration timing:prospective
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Elnaz Shaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
shasebe@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of coadministration of Pioglitazone and Vitamin E compared to coadministration Metformin and Ursodeoxycholic acid (UDCA) on ultrasound scoring and liver enzymes in patients with non-alcoholic fatty liver
Public title
"Evaluation of the effect of Pioglitazone and Vitamin E in Fatty Liver", "The effect of Metformin and UDCA on Fatty Liver"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 years
Patients who have been diagnosed with non-alcoholic fatty liver based on ultrasound evidence and tests
People with controlled diabetes (HbA1C below 8%)
Exclusion criteria:
People with heart failure (HF) Classes 3 and 4
People with kidney failure (GFR <30)
People with liver cirrhosis
People with bladder cancer
People with Osteoporosis
Pregnant and lactating women
alcohol consumption
People who also use other vitamins containing vitamin E at the same time
People receiving warfarin
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
158
Randomization (investigator's opinion)
Randomized
Randomization description
Random method and description of each method: simple randomization, block
Arrange the accident stages:
1) Determine the volume of each block (Foursquare blocks)
2) Prepare block lists and assign numbers to them
AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6)
3) Selection of random numbers between 1 and 6
4) Identification of the Treatment Assignment
For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
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 Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.TBZMED.REC.1397.445
Health conditions studied
1
Description of health condition studied
Fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Grade ultrasound
Timepoint
At the beginning of the study, 3 months and 6 months later
Method of measurement
Sonography
2
Description
Liver Enzymes(AST , ALT)
Timepoint
At the beginning of the study, 3 months and 6 months later
Method of measurement
Blood test
Secondary outcomes
1
Description
Lipid profile
Timepoint
At the beginning of the study, 3 and 6 months later
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group 1: Individuals receiving Pioglitazone plus Vitamin E: People in this group will receive Pioglitazone 15 mg and Vitamin E 800 mg (400 mg twice daily, Zahravi factory) on a daily basis for 6 months, as well as all patients at the time of arrival, Three months later, at the end of the study (6 months later), blood samples were taken to determine the level of liver enzymes and ultrasound to determine the grade of fatty liver. Measuring the level of liver enzymes in the "Danesh" lab and doing ultrasound at the "Tabesh" imaging center
Category
Treatment - Drugs
2
Description
Intervention group 2: Individuals receiving Metformin plus Ursodeoxycholic acid: People in this group will receive Metformin at a dose of 500 mg daily and Ursodeoxy cholic acid at a dose of 300 mg (three times a day, making a So.se Italian factury) on a daily basis for 6 months, as well as all patients at the time of arrival, Three months later, at the end of the study (6 months later), blood samples were taken to determine the level of liver enzymes and ultrasound to determine the grade of fatty liver. Measuring the level of liver enzymes in the "Danesh" lab and doing ultrasound at the "Tabesh" imaging center
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Teaching Hospital of Tabriz
Full name of responsible person
Manuchehr khoshbaten MD
Street address
Golgasht, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
59-3347054
Phone
+98 41 3334 7054
Fax
Email
info@imamreza.tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Hamedyazdan MD
Street address
Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 7459
Fax
+98 41 3334 4798
Email
yazdan@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
30
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 Elnaz Shaseb
Position
Member of the faculty of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz Medical University, Golgaste St, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1449
Email
elnaz_shaseb_64@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Elnaz Shaseb
Position
Member of the faculty of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz Medical University, Golgaste St, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51666414766
Phone
+98 41 3334 1449
Email
elnaz_shaseb_64@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Milad Ahadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz Medical University, Golgaste St, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3728 7256
Email
milad.ahadi.22@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available