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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Protocol summary
A clinical trial based, pragmatic, parallel-group, non-randomized, unblinded, phase 2 controlled clinical trial on 116 patients.
A clinical trial based, pragmatic, parallel-group, randomized, unblinded, phase 2 controlled clinical trial on 116 patients.
A clinical trial based, pragmatic, parallel-group, non-randomized, unblinded, phase 2 controlled clinical trial on 116 patients.
کار آزمایی بالینی دارای گروه کنترل مبتنی بر جامعه و عملگرا ، با گروه موازی ، غیر تصادفی شده،کور نشده ،فاز ۲ بر روی 116 بیمار
کار آزمایی بالینی دارای گروه کنترل مبتنی بر جامعه و عملگرا، با گروه موازی، تصادفی شده، کور نشده، فاز ۲ بر روی 116 بیمار
کار آزمایی بالینی دارای گروه کنترل مبتنی بر جامعه و عملگرا، با گروه موازی، غیر تصادفی شده،کور نشده،فاز ۲ بر روی 116 بیمار
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.
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
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 indicesThis study selected 68 people who were examined and compared before and after taking empagliflozin at doses of 10 and 25 mg.divided equally into two groups
گروه آزمایش شامل 116 بیمار در دو گروه 58 تایی مبتلا به کبد چرب غیر الکلی و پره دیابت و غیر دیابتی می باشند که به مدت سه ماه تحت درمان با داروی امپاگلیفلوزین در دوزهای ۱۰ میلی گرم و ۲۵ میلی گرم قرار می گیریند بررسی و مقایسه نتایج آزمایشات آنزیم های کبدی و شاخص های آنتروپرومتریک قبل و بعد از مصرف داروی امپاگلیفلوزین در دوزهای ۱۰ و ۲۵ میلی گرم است.
گروه آزمایش شامل ۱۱۶ بیمار در دو گروه 58 تایی مبتلا به کبد چرب غیر الکلی و پره دیابت و غیر دیابتی می باشند که به مدت سه ماه تحت درمان با داروی امپاگلیفلوزین در دوزهای ۱۰ میلی گرم و ۲۵ میلی گرم قرار می گیریند در.این مطالعه ۶۸ نفر وارد که بهصورت مساوی به دو گروه تقسیم شدند (۳۵ نفر در گروه ۱۰ میلیگرم و ۳۳ نفر در گروه ۲۵ میلیگرم در پایان
گروه آزمایش شامل 116۱۱۶ بیمار در دو گروه 58 تایی مبتلا به کبد چرب غیر الکلی و پره دیابت و غیر دیابتی می باشند که به مدت سه ماه تحت درمان با داروی امپاگلیفلوزین در دوزهای ۱۰ میلی گرم و ۲۵ میلی گرم قرار می گیریند بررسی و مقایسه نتایج آزمایشات آنزیم های کبدی و شاخص های آنتروپرومتریک قبل و بعد از مصرف داروی امپاگلیفلوزیندر.این مطالعه ۶۸ نفر وارد که بهصورت مساوی به دو گروه تقسیم شدند (۳۵ نفر در دوزهایگروه ۱۰ میلیگرم و ۳۳ نفر در گروه ۲۵ میلیگرم است.در پایان
General information
Not randomized
Randomized
nrandrand
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68
68
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2025-04-21, 1404/02/01
2025-04-21 00:00:00
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2025-08-23, 1404/06/01
2025-08-23 00:00:00
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2025-09-23, 1404/07/01
2025-09-23 00:00:00
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Update results and corrections
Update results and corrections
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به روز رسانی نتایج و اصلاحات
به روز رسانی نتایج و اصلاحات
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.
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.
در این مطالعه ۶۸ نفر انتخاب شدند که بهصورت مساوی به دو گروه تقسیم گردیدند. (۳۵ نفر در گروه ۱۰ میلیگرم و ۳۳ نفر در گروه ۲۵ میلیگرم در پایان مطالعه).
تخصیص نمونه ها به دو گروه تصادفی بلوکی و با استفاده از حساسیت sealed envelope انجام شد.
برای تصادفیسازی، از روش تخصیص تصادفی بلوکی (Block Randomization) استفاده شد. جهت تولید توالی تصادفی، از وبسایت https://www.sealedenvelope.com بهصورت آنلاین بهرهگیری شد. بلوکهایی با اندازه ۶ نفره طراحی گردید و در مجموع ۱۲ بلوک ۶ تایی ایجاد شد که نهایتاً ۳۵ بیمار در گروه ۱۰ میلیگرم و ۳۳ بیمار در گروه ۲۵ میلیگرم بهصورت تصادفی تخصیص یافتند.
در این مطالعه ۶۸ نفر انتخاب شدند که بهصورت مساوی به دو گروه تقسیم گردیدند. (۳۵ نفر در گروه ۱۰ میلیگرم و ۳۳ نفر در گروه ۲۵ میلیگرم در پایان مطالعه). تخصیص نمونه ها به دو گروه تصادفی بلوکی و با استفاده از حساسیت sealed envelope انجام شد. برای تصادفیسازی، از روش تخصیص تصادفی بلوکی (Block Randomization) استفاده شد. جهت تولید توالی تصادفی، از وبسایت https://www.sealedenvelope.com بهصورت آنلاین بهرهگیری شد. بلوکهایی با اندازه ۶ نفره طراحی گردید و در مجموع ۱۲ بلوک ۶ تایی ایجاد شد که نهایتاً ۳۵ بیمار در گروه ۱۰ میلیگرم و ۳۳ بیمار در گروه ۲۵ میلیگرم بهصورت تصادفی تخصیص یافتند.
Sharing plan
محققین شاغل در موسسات داشگاهی و علمی
محققین شاغل در موسسات دانشگاهی و علمی
محققین شاغل در موسسات داشگاهیدانشگاهی و علمی
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, 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. This study selected 68 people who were divided equally into two groups
Main outcome variables
AST,ALT,FIB-4, anthropometri
General information
Reason for update
Update results and corrections
Acronym
IRCT registration information
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
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
Recruitment complete
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
2025-04-21, 1404/02/01
Actual recruitment end date
2025-08-23, 1404/06/01
Trial completion date
2025-09-23, 1404/07/01
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
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
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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
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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
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