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Comparing the effects of doses empagliflozin 10 mg and 25 mg on anthropometric index and liver enzymes in patients with non alcoholic fatty liver (NAFLD)

Protocol summary

Study aim
Comparing the effects of doses empagliflozin 10 mg and 25 mg on anthropometric index and liver enzymes in patients with non alcoholic fatty liver (NAFLD)
Design
A clinical trial based, pragmatic, parallel-group, non-randomized, unblinded, phase 2 controlled clinical trial on 116 patients.
Settings and conduct
It is a clinical trial study and will be conducted for three months in clinics in Zanjan in 1404. Patients with non-alcoholic fatty liver disease will be divided into two groups. The weight-stabilizing diet will be set for patients and it is recommended that they walk at a moderate pace for a maximum of half an hour daily. Anthropometric and paraclinical indices will be recorded at the beginning and end of the study. Also, the FIB4 index will be calculated using the formula..
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients with non alcoholic fatty liver (NAFLD)referred to Gastroenterology and endocrine clinics of Zanjan city ,Patients with fasting blood sugar between 90 and 125 mg/dL ,Patients with HBA1C less than 6.5% ,ALT greater than 1.5 to 5 times normal,Body mass index (BMI) ≥24 ; Exclusion criteria:Patients with other secondary causes of fatty liver (viral and alcoholic osteohepatitis, Wilson's disease, hemochromatosis, metabolic liver disease), Patients taking any type of medication that affects the liver (phenytoin, amiodarone, tamoxifen, birth control pills, levothyroxine, estrogen, corticosteroids, etc.)
Intervention groups
The experimental group consisted of 116 patients in two groups of 58 each with non-alcoholic fatty liver disease, prediabetes, and non-diabetes, who were treated with empagliflozin at doses of 10 mg and 25 mg for three months. The results of liver enzyme tests and anthropometric indices were examined and compared before and after taking empagliflozin at doses of 10 and 25 mg.
Main outcome variables
AST,ALT,FIB-4, anthropometri

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250314065071N1
Registration date: 2025-03-17, 1403/12/27
Registration timing: prospective

Last update: 2025-03-17, 1403/12/27
Update count: 0
Registration date
2025-03-17, 1403/12/27
Registrant information
Name
Mehran Nezamdiba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3343 6086
Email address
mehrandiba@zums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of doses empagliflozin 10 mg and 25 mg on anthropometric index and liver enzymes in patients with non alcoholic fatty liver (NAFLD)
Public title
Comparing the effects of doses empagliflozin 10 mg and 25 mg on anthropometric index and liver enzymes in patients with non alcoholic fatty liver (NAFLD)
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
patients with non alcoholic fatty liver (NAFLD)referred to Gastroenterology and endocrine clinics of Zanjan city Patients with fasting blood sugar between 90 and 125 mg/dL Patients with HBA1C less than 6.5% ALT greater than 1.5 to 5 times normal Body mass index (BMI) ≥24
Exclusion criteria:
Patients with other secondary causes of fatty liver (viral and alcoholic osteohepatitis, Wilson's disease, hemochromatosis, metabolic liver disease) Patients taking any type of medication that affects the liver (phenytoin, amiodarone, tamoxifen, birth control pills, levothyroxine, estrogen, corticosteroids, etc.)
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 116
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Comparing the effects of doses empagliflozin 10 mg and 25 mg on anthropometric index and liver enzymes in patients with non alcoholic fatty liver (NAFLD)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zanjan University of medical Sciences
Street address
Zanjan, Azadi Boulevard, Zanjan University of Medical Sciences, Research Vice-Chancellor
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2025-03-04, 1403/12/14
Ethics committee reference number
IR.ZUMS.REC.1403.353

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
Aspart Aminotransferase (AST)
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Aspart Aminotransferase specific laboratory kit

2

Description
Alanine Aminotransferase
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Alanine Aminotransferase specific laboratory kit

3

Description
Average changes in FIB-4 criteria
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Laboratory kit for Aspart Aminotransferase and Platelet, then using FIB-4 formula

4

Description
Anthropometric index includes weight, height, BMI, waist circumference, hip circumference, and waist-to-hip ratio.
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
The method of measuring the weight variable of individuals will be measured with a seca scale with an accuracy of 0.1 kg, without shoes and with minimal clothing. The height, waist and hip circumference of individuals will also be measured using a non-elastic meter with an accuracy of 0.5 cm. The body mass index will also be calculated for each individual with the formula BMI = 2 (m) height / (Kg) weight. Also, the formula hip circumference / waist circumference = WHR will be used to calculate the waist-to-hip ratio.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention groupA: Recipients will receive 10 mg of empagliflozin once daily for 3 months, and a weight-stabilizing diet that provides 26-27 kcal per kilogram of energy, with 50-55% of daily energy coming from carbohydrates, 15% from protein, and 30-35% from fat, will be adjusted for patients.Anthropometric index as well as paraclinical data including AST, ALT, CBC will be recorded at the beginning and end of the study. Also, FIB4 index will be calculated using the formula. Manufacturer: Abidi Pharmaceutical Company
Category
Treatment - Drugs

2

Description
Intervention groupB:Recipients will receive 25 mg of empagliflozin once daily for 3 months, and a weight-stabilizing diet that provides 26-27 kcal per kilogram of energy, with 50-55% of daily energy coming from carbohydrates, 15% from protein, and 30-35% from fat, will be adjusted for patients.Anthropometric index as well as paraclinical data including AST, ALT, CBC will be recorded at the beginning and end of the study. Also, FIB4 index will be calculated using the formula. Manufacturer: Abidi Pharmaceutical Company
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Zanjan, Vali-e-Asr Hospital
Full name of responsible person
Dr. Mehran Nezam Diba
Street address
Zanjan, Valiasr Square, Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9028
Email
Mehrandiba@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehrdad Hamidi
Street address
Zanjan, Sheikh Fadlallah Nouri Highway, Valiasr Square, Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9028
Email
hamidim@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Sahar Shafagh
Position
Resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zanjan, Sheikh Fadlallah Nouri Highway, Valiasr Square, Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9028
Email
Saharshafagh323@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Mehran Nezam Diba
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Zanjan, Sheikh Fadlallah Nouri Highway, Valiasr Square, Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9028
Email
Mehrandiba@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Sahar Shafagh
Position
Resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zanjan, Sheikh Fadlallah Nouri Highway, Valiasr Square, Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9028
Email
Saharshafagh323@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
Age, gender, and demographic information of patients, as well as test results and questionnaires containing patients' symptoms at the beginning, during, and end of the treatment period, with the removal of patients' personal details, as well as some of the data, such as information related to the main outcome, can be published.
When the data will become available and for how long
When publishing, documents and files will be available online after the completion of the project with the permission of the Ethics Committee of Zanjan University of Medical Sciences
To whom data/document is available
Researchers working in universities and scientific institutions
Under which criteria data/document could be used
By adhering to the ethical principles of confidentiality, information, documentation, and all investigations conducted can be published.
From where data/document is obtainable
Mehrandiba@zums.ac.ir
What processes are involved for a request to access data/document
Send an email and make a request
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