Protocol summary
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Study aim
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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)
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Design
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A clinical trial based, pragmatic, parallel-group, randomized, unblinded, phase 2 controlled clinical trial on 116 patients.
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Settings and conduct
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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..
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Participants/Inclusion and exclusion criteria
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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.)
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Intervention groups
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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. This study selected 68 people who were divided equally into two groups
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Main outcome variables
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AST,ALT,FIB-4, anthropometri
General information
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Reason for update
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Update results and corrections
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250314065071N1
Registration date:
2025-03-17, 1403/12/27
Registration timing:
prospective
Last update:
2026-02-06, 1404/11/17
Update count:
1
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Registration date
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2025-03-17, 1403/12/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-04-21, 1404/02/01
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Expected recruitment end date
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2025-08-23, 1404/06/01
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Actual recruitment start date
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2025-04-21, 1404/02/01
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Actual recruitment end date
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2025-08-23, 1404/06/01
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Trial completion date
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2025-09-23, 1404/07/01
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Scientific title
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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)
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Public title
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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)
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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.)
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
116
Actual sample size reached:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, 68 people were selected and divided equally into two groups. (35 people in the 10 mg group and 33 people in the 25 mg group at the end of the study).
The allocation of samples to two random block groups was done using sealed envelope sensitivity.
For randomization, the block randomization method was used. To generate the random sequence, the website https://www.sealedenvelope.com was used online. Blocks of 6 people were designed and a total of 12 blocks of 6 were created, which ultimately randomly assigned 35 patients to the 10 mg group and 33 patients to the 25 mg group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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)
Ethics committees
1
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Ethics committee
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Approval date
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2025-03-04, 1403/12/14
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Ethics committee reference number
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IR.ZUMS.REC.1403.353
Health conditions studied
1
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Description of health condition studied
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Non alcoholic fatty liver
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Aspart Aminotransferase (AST)
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Timepoint
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At the beginning of the study and after 12 weeks
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Method of measurement
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Aspart Aminotransferase specific laboratory kit
2
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Description
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Alanine Aminotransferase
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Timepoint
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At the beginning of the study and after 12 weeks
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Method of measurement
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Alanine Aminotransferase specific laboratory kit
3
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Description
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Average changes in FIB-4 criteria
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Timepoint
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At the beginning of the study and after 12 weeks
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Method of measurement
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Laboratory kit for Aspart Aminotransferase and Platelet, then using FIB-4 formula
4
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Description
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Anthropometric index includes weight, height, BMI, waist circumference, hip circumference, and waist-to-hip ratio.
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Timepoint
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At the beginning of the study and after 12 weeks
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Method of measurement
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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.
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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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
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To whom data/document is available
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Researchers working in universities and scientific institutions
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Under which criteria data/document could be used
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By adhering to the ethical principles of confidentiality, information, documentation, and all investigations conducted can be published.
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From where data/document is obtainable
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Mehrandiba@zums.ac.ir
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What processes are involved for a request to access data/document
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Send an email and make a request
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Comments
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