The effect of pioglitazone on the improvement of non-alcoholic fatty liver in obese patients
Design
Clinical trial with control group with parallel groups, phase 2-3 on 44 patients
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients in the intervention group will be treated with pioglitazone tablets and their degree of non-alcoholic fatty liver will be measured before and after the interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 65 years, candidate for bariatric surgery, non-alcoholic fatty liver disease grade 3, satisfaction with inclusion in the study
Exclusion criteria: daily consumption of more than 40 grams and 20 grams of alcohol for men and women, respectively, having other liver diseases, liver cancer, taking hepatotoxic drugs
Intervention groups
Intervention group: Patients in this group are examined for the degree of fatty liver and then for 4 months, in addition to dietary recommendations, will receive pioglitazone 15 mg tablets 2 times a day. After the interventions, the degree of fatty liver will be measured again.
Control group: Patients in this group will be examined for the degree of fatty liver and will only receive routine dietary recommendations and after 4 months their fatty liver will be measured again.
Main outcome variables
Fatty liver grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N3
Registration date:2021-08-07, 1400/05/16
Registration timing:prospective
Last update:2021-08-07, 1400/05/16
Update count:0
Registration date
2021-08-07, 1400/05/16
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-04, 1400/06/13
Expected recruitment end date
2021-10-05, 1400/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pioglitazone on the improvement of non-alcoholic fatty liver in obese patients
Public title
Pioglitazone and non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
Candidate for bariatric surgery
Non-alcoholic fatty liver disease grade 3
Satisfaction with inclusion in the study
Exclusion criteria:
Daily consumption of more than 40 grams and 20 grams of alcohol for men and women, respectively
Having other liver diseases
Liver cancer
Taking hepatotoxic drugs
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:
44
Randomization (investigator's opinion)
Not 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 Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MUI.MED.REC.1398.053
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Fatty liver grade
Timepoint
Before and 4 months after treatment
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group are examined for the degree of fatty liver and then for 4 months, in addition to dietary recommendations, will receive pioglitazone 15 mg tablets 2 times a day. After the interventions, the degree of fatty liver will be measured again.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will be examined for the degree of fatty liver and will only receive routine dietary recommendations and after 4 months their fatty liver will be measured again.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Masoud Sayadi
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.