Evaluation of the effect of Empagliflozine on inflammatory, oxsidative stress and biochemistry markers in patients with non-alchoholic fatty liver disease in comparison with control group
Determinig the effect of Empagliflozine on inflammatory, oxsidative stress and biochemistry markers in patients with non-alchoholic fatty liver disease in comparison with control group
Design
A controlled, parallel-group, unblinded, randomized, phase 3 clinical trial of 40 patients. The block method will be used to assign people to the studied groups.
Settings and conduct
At first, biochemical, oxidative and inflammatory stress tests will be taken from all the people of both groups. Then empagliflozin drug (10 mg/day) (4), diet and exercise program will be prescribed for the experimental group and only diet for the control group. Participants perform the interventions at home.
Yasouj University is the place where interventions are carried out.
Participants/Inclusion and exclusion criteria
Inclusuion criteria:
1-Having findings of non-alcoholic fatty liver in the ultrasound of people over 18 years old, as well as ALT more than 33 in men and more than 25 in non-diabetic women
2-Desire to participate in the study
3-Age over 18 years
4-No history of alcohol consumption or consumption of less than 20 grams of alcohol per day in women and less than 30 grams per day in men
5-Absence of other liver disorders
1-No interest in participating
2-Pregnancy or breastfeeding in female
Intervention groups
Intervention: Empagliflozin (10 mg/day) for 8 weeks along with diet and exercise
Control: diet and exercise for 8 weeks
Main outcome variables
Decrease in liver enzymes; Reducing the amount of inflammatory factor; Reduction of oxidative stress markers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240326061366N1
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Pouya Akhoondi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5153
Email address
pouyaakhoondi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-01-09, 1403/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Empagliflozine on inflammatory, oxsidative stress and biochemistry markers in patients with non-alchoholic fatty liver disease in comparison with control group
Public title
Effect of Empagliflozine on fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages greater than 18
Fatty liver sonography findings
ALT levels greater than 33 in non diabetic male and greater than 25 in non diabetic female
Personal interest to participate
Consumption of non or less than 20 grams of alcohol per day in female and non or less than 30 grams of alcohol per daY in male
No history of malignancies,cardiovascular respiratory and renal complications,
No history of weight loss or weight loss surgery
No history of drug consumption and no history of metabolic and endocrine complications
No history of liver enhancing drugs such as Vit E,Liver goal,Liver med ...
Exclusion criteria:
No interest in participating
Pregnancy or breastfeeding in female
No drug use compatibility
Allergy to Empagliflozine
Participating in other clinical studies
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The block method will be used to assign people to the studied groups. The advantages of block randomization are that the balance of the number of patients in each group is guaranteed. The groups are defined as A and B codes. Before assigning people to one of the groups, a list of these letters (A, B) is formed in the form of blocks. Each of the referring and qualified people is assigned to one of the groups. To avoid the risk of predictable allocation People in different groups, blocks with different sizes (2,4,6 and 8) will be created
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciencest, Shahid Jalil blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.YUMS.REC.1402.185
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
Alanine transaminase
Timepoint
Before the start of study and 8 weeks after intervention
Method of measurement
Calorimetry withhitachi autoanalyzer 7020
Secondary outcomes
1
Description
C reactive protein
Timepoint
Before intervention and 8 weeks after the start of intervention
Method of measurement
Laser nephelometry
Intervention groups
1
Description
Intervention group: Empagliflozine receivers with dose of 10mg po daily for 8 weeks from Abidipharma company
Category
Treatment - Drugs
2
Description
Control group: patients in this group receive diet program for reducing the calorie intake by reducing the amount of carbohydrates and also receive exercise program which includes walking for 30 minutes a day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofatteh clinic nomber 1
Full name of responsible person
Zahra Rahami
Street address
15 TH Golestan street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 9101 3813
Email
name@domian.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin hossaini motlagh
Street address
Motahari blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
no grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
40
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
2
Sponsor
Name of organization / entity
Doosti motlagh laboratory
Full name of responsible person
Amirhossein doosti motlagh
Street address
Pasdaran blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591867319
Phone
+98 937 531 7741
Email
amirhosseindoustimotlagh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Amirhossein doosti motlagh
Proportion provided by this source
60
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amirhossein Doostimotlagh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Laboratory Medicine
Street address
Yasuj university of medical sciences, Saheli blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591867319
Phone
+98 74 3323 5153
Fax
Email
amirhosseindoustimotlagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amirhossein Doostimotlagh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Laboratory Medicine
Street address
Yasuj university of medical sciences, Saheli blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591867319
Phone
+98 74 3323 5153
Fax
Email
amirhosseindoustimotlagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Pouya Akhoondi
Position
Researcher
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Yasuj university of medical sciences, Saheli blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7186776571
Phone
+98 74 3323 5153
Fax
Email
pouyaakhoondi@yahoo.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
data related to primary outcome measure
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Medical field researchers
Under which criteria data/document could be used
Available for public if data are not abused
From where data/document is obtainable
pouyaakhoondi@yahoo.com
pouya akhoondi
What processes are involved for a request to access data/document