1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of empagliflozin on thyroid function in patients with non-alcoholic fatty liver disease (NAFLD)

Protocol summary

Study aim
Determination the effect of Empagliflozin on thyroid function in patients with non-alcoholic fatty liver disease (NAFLD) referred to Shahid Mofateh Clinic in Yasuj city
Design
The clinical trial will have a control group, with parallel groups, double-blind, blocked randomization, phase 3 on 40 patients, the sample size in each group will be 20 people. The software used is G power version 3.1.9.4.
Settings and conduct
After identifying patients eligible for inclusion in the study from among those referred to the Shahid Mofatteh Clinic , the patients were divided into two groups in a block randomization manner providing.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study were non-alcoholic fatty liver disease (NAFLD) on ultrasound in individuals over 18 years of age, as well as ALT greater than 33 in men and greater than 25 in non-diabetic women. After identifying the patients, they were divided into two groups of 20 . Exclusion criteria:Alcohol consumption more than 20 grams per day/History of hepatitis B or C virus infection/Autoimmune hepatitis/Other liver diseases/Taking any hepatotoxic or thyroid medication/Diabetes/Pregnancy/breastfeeding/History of cancer or treatment for thyroid cancer within the past 2 years/BMI more than 40
Intervention groups
Initially, tests (ALT, AST, Fatty liver grade 1, grade 2, grade 3, T4, TSH) are taken from all individuals in both groups. Then, for the experimental group, the drug empagliflozin (10 mg/day)(4) is prescribed once a day orally, along with a diet and exercise program, and for the control group, only a diet and exercise program is applied.The exercise program includes 30 minutes of daily walking, and the diet plan includes a 10% reduction in daily calorie intake from carbohydrate intake
Main outcome variables
ALT; AST; ALKP; TSH; T4; T3

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250713066469N1
Registration date: 2025-07-30, 1404/05/08
Registration timing: prospective

Last update: 2025-07-30, 1404/05/08
Update count: 0
Registration date
2025-07-30, 1404/05/08
Registrant information
Name
Neda Saeedinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 9236
Email address
neda.sdi77@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-21, 1405/01/01
Expected recruitment end date
2027-03-21, 1406/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empagliflozin on thyroid function in patients with non-alcoholic fatty liver disease (NAFLD)
Public title
Investigating the effect of empagliflozin on thyroid function in patients with non-alcoholic fatty liver disease (NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 30 to 70 years Non-alcoholic fatty liver disease (confirmed by ultrasound)
Exclusion criteria:
Alcohol consumption of more than 20 grams per day History of hepatitis B or C virus infection, autoimmune hepatitis, other liver diseases Taking any hepatotoxic or thyroid medications pregnancy / breastfeeding History of cancer or treatment for thyroid cancer within the past 2 years BMI more than 40
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking will be used to assign individuals to the study groups. The advantages of blocked randomization are that it ensures a balance in the number of patients in each group. The groups are defined as codes A and B. Before assigning individuals to one of the groups, a list of these letters (A, B) is formed, in other words, blocks. Each of the referring and eligible individuals is assigned to one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding was performed for patients and the researcher and they were unaware of the drug group they received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj univercity of medical scienes
Street address
Yasuj university of medical seinces; Motahari Blvd; Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2025-04-23, 1404/02/03
Ethics committee reference number
IR.YUMS.REC.1404.007

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
TSH
Timepoint
o-3-6 months
Method of measurement
Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone, thyroxine and triiodothyronine. All values will be measured by standard methods.

2

Description
T4
Timepoint
o-3-6 months
Method of measurement
Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone; thyroxine and triiodothyronine. All values will be measured by standard methods.

3

Description
T3
Timepoint
o-3-6 months
Method of measurement
Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone; thyroxine and triiodothyronine. All values will be measured by standard methods.

Secondary outcomes

1

Description
Alanine aminotransferase
Timepoint
0-3-6 months
Method of measurement
Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).

2

Description
Aspartate aminotransferase
Timepoint
0-3-6 months
Method of measurement
Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).

3

Description
Alkaline phosphatase
Timepoint
0-3-6 months
Method of measurement
Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).

4

Description
fatty liver grade
Timepoint
0-3-6 months
Method of measurement
Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).

Intervention groups

1

Description
They received the drug empagliflozin.
Category
Treatment - Drugs

2

Description
Control group: Diet and exercise
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mofatteh 2 Clinic, Yasuj
Full name of responsible person
Mohamad Marashi
Street address
Golestan 15 street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591765432
Phone
+98 74 9101 3813
Email
cngfdgnfn@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sirus Salehnasab
Street address
Yasuj University of Medical Sciences Headquarters; Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6079
Email
research@yums.ac.ir
Grant name
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
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
Yasouj University of Medical Sciences
Full name of responsible person
Neda Saeedinasab
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moalem street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591797569
Phone
+98 917 810 8067
Email
neda.sdi77@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zahra Rahami
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Yasuj university of medical siences., Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 917 145 4809
Email
z.rahami.65@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Neda Saeedinasab
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Moalem street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591797569
Phone
+98 917 810 8067
Email
neda.sdi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
I haven't decided yet.
When the data will become available and for how long
one yeari
To whom data/document is available
I haven't decided yet.
Under which criteria data/document could be used
...
From where data/document is obtainable
Yasuj university of medical sciencesهنوز تصمیم
What processes are involved for a request to access data/document
I haven't decided yet.
Comments
Loading...