Evaluation of the effect of empagliflozin in combination with pioglitazone on fatty liver disease in type 2 diabetic patients referred to Imam Reza hospital during December 2022 to December 2023.
Investigating the effect of empagliflozin in combination with pioglitazone on the course of fatty liver disease in type 2 diabetic patients
Design
This study includes two groups that are randomly divided into two groups after matching in terms of age and sex. Both groups will receive medication.
Settings and conduct
This study will be done in Imam Reza Hospital. Diabetic patients who refer to the endocrinology clinic of this hospital will be included in the study after obtaining consent. The first group received pioglitazone daily and the second group received pioglitazone plus empagliflozin, and then in terms of liver indices before and after the case study will be reviewed.
Participants/Inclusion and exclusion criteria
Inclusion criteria included T2DM and NAFLD based on fatty liver grade in liver ultrasound. Patients with grade 1 and above were included in the study. Exclusion criteria included type 1 diabetes, active or chronic hepatitis, cirrhosis and biliary disease, class III and IV heart failure, renal dysfunction, GFR<45, history of alcohol consumption (20 grams per day in women and 30 grams per day in men), consumption Non-steroidal anti-inflammatory drugs, use of supplements such as vitamin C, zinc, selenium or antioxidant agents , history of cardiovascular events in the last 3 months, pregnancy and breastfeeding, active cancer or history of cancer treatment in the last 2 years, untreated thyroid disorder or body mass index above 40 kg/m2.
Intervention groups
Two groups of 42 and 43 people were included in the study. The first group will receive pioglitazone and the second group will receive daily pioglitazone plus empagliflozin.
Main outcome variables
Nafld fibrosis score%; APRI ratio %; FIB-4 index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240208060939N1
Registration date:2024-03-03, 1402/12/13
Registration timing:retrospective
Last update:2024-03-03, 1402/12/13
Update count:0
Registration date
2024-03-03, 1402/12/13
Registrant information
Name
Afsaneh vosoghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4601 0322
Email address
afsaneh.vosoghi.1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of empagliflozin in combination with pioglitazone on fatty liver disease in type 2 diabetic patients referred to Imam Reza hospital during December 2022 to December 2023.
Public title
Evaluation of the effect of empagliflozin in combination with pioglitazone on fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes and fatty liver at the same time
Exclusion criteria:
Active or chronic hepatitis, cirrhosis and biliary disease
Class III and IV heart failure
Renal dysfunction GFR<45
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were included in the study using available sampling method and after matching in terms of age and gender, they were divided into two groups, intervention and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of AJA University of Medical Sciences
Street address
Fatemi Street, Eetemad Zadeh street, Aja university of medical sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2023-01-13, 1401/10/23
Ethics committee reference number
IR.AJAUMS.REC.1401.009
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
AST,ALT
Timepoint
0, 24 Week after
Method of measurement
Laboratory
2
Description
CAP score
Timepoint
0, 24 Week after
Method of measurement
Sonography/Fibro Scan
3
Description
Nafld fibrosis score
Timepoint
0, 24 Week after
Method of measurement
D fibrosis score = -1.675+0.037-age(years)+0.094-BMI(kg/m^2)+1.13× IFG/diabetes(yes=1,no=0)+0.99×AST/ALTratio-0.013×PLT- 0.66×albumin
4
Description
APRI ratio
Timepoint
0, 24 Week after
Method of measurement
AST/PLT ratio
5
Description
FIB-4 index
Timepoint
0, 24 Week after
Method of measurement
Age (years)×AST (U/L)/[PLT(109/L)×ALT1/2 (U/L)]
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive 15 to 30 mg of pioglitazone daily for 24 weeks.
Category
Treatment - Drugs
2
Description
Control group: This group will receive 15 to 30 mg of pioglitazone plus 10 mg of empagliflozin daily for 24 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Afsaneh Vosughi
Street address
Fatemi Street, Etemad zadeh street, AJA university of medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 912 528 0962
Email
afsaneh.vosoghi.1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Reza Mosaed
Street address
AJA University of Medical Sciences, Eetemad Zadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
afsaneh.vosoghi.1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Afsaneh Vosoghi
Position
Internal Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
AJA University of Medical Sciences, Eetemad Zadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
afsaneh.vosoghi.1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Afsaneh Vosughi
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
AJA University of Medical Sciences, Eetemad Zadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
afsaneh.vosoghi.1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
afsaneh vosoghi
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
AJA University of Medical Sciences, Eetemad Zadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
afsaneh.vosoghi.1@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
The data will be made available in the form of articles
When the data will become available and for how long
Considering that the data will be available in the form of an article, there is no specific time frame for this.
To whom data/document is available
All the people who will have access to the article published in the journal.
Under which criteria data/document could be used
For the use of researchers
From where data/document is obtainable
The website of the journal in which the article was published
What processes are involved for a request to access data/document
So access to the journal site where the article is published and in accordance with the rules of the journal