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IRCT20250314065071N1 IRCT 2025-03-17 Zanjan University of Medical Sciences 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) 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) 2025-04-21 anticipated 116 Complete https://irct.ir/trial/82474 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, 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), 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. 2 Non alcoholic fatty liver. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 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: Researchers working in universities and scientific institutions Conditions: By adhering to the ethical principles of confidentiality, information, documentation, and all investigations conducted can be published. Where to obtain: Mehrandiba@zums.ac.ir How to obtain: Send an email and make a request Comments:
public Dr.Sahar Shafagh
Zanjan, Sheikh Fadlallah Nouri Highway, Valiasr Square, Valiasr Hospital
Zanjan Iran (Islamic Republic of) 4515777978 +98 24 3373 9028 Saharshafagh323@gmail.com Zanjan University of Medical Sciences scientific Dr.Mehran Nezam Diba
Zanjan, Sheikh Fadlallah Nouri Highway, Valiasr Square, Valiasr Hospital
Zanjan Iran (Islamic Republic of) 4515777978 +98 24 3373 9028 Mehrandiba@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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.) K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs 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 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 Aspart Aminotransferase (AST). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Aspart Aminotransferase specific laboratory kit. Alanine Aminotransferase. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Alanine Aminotransferase specific laboratory kit. 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. 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. Zanjan University of Medical Sciences Approved 2025-03-04 Zanjan University of medical Sciences Zanjan, Azadi Boulevard, Zanjan University of Medical Sciences, Research Vice-Chancellor Zanjan Zanjan Iran (Islamic Republic of)