Metabolic Dysfunction-Associated Liver Disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Participants in this group will receive one oral empagliflozin 10 mg tablet daily for 3 months. The medication will be administered orally once daily. In addition t
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Absence of diabetes mellitus defined as fasting plasma glucose <126 mg/dL and HbA1c <6.5% Willingness to participate and provide written informed consent Ability to comply with study follow-up visits
Exclusion criteria
Exclusion criteria: Significant alcohol consumption during the past two years Presence of other chronic liver diseases, such as chronic viral hepatitis or autoimmune hepatitis Drug-induced liver disease Use of medications known to induce hepatic steatosis, such as corticosteroids, amiodarone, valproate, methotrexate, or tamoxifen Use of medications specifically prescribed for fatty liver disease, such as vitamin E or pioglitazone Decompensated cirrhosis History of malignancy, including hepatocellular carcinoma Recreational drug or substance abuse Pregnancy Contraindications to empagliflozin, such as eGFR <45 mL/min/1.73 m²
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hepatic steatosis. Timepoint: before initiation of intervention and at the end of 3 months after intervention. Method of measurement: using liver FibroScan examination.;Change in hepatic fibrosis. Timepoint: before initiation of intervention and at the end of 3 months after intervention. Method of measurement: using liver FibroScan examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in liver enzyme levels. Timepoint: at baseline and at the end of 3 months after intervention. Method of measurement: using blood testing and laboratory autoanalyzer.;Change in body mass index. Timepoint: at baseline and at the end of 3 months after intervention. Method of measurement: body weight and height measured by calibrated scale and stadiometer.;Change in blood pressure. Timepoint: at baseline and at the end of 3 months after intervention. Method of measurement: using a standard sphygmomanometer.;Serum ferritin level. Timepoint: at baseline and at the end of 3 months after intervention. Method of measurement: using laboratory immunoassay method.;Serum creatinine level. Timepoint: at baseline and at the end of 3 months after intervention. Method of measurement: using blood testing and laboratory autoanalyzer.;Fasting blood glucose level. Timepoint: at baseline and at the end of 3 months after intervention. Method of measurement: using blood sampling after 8 to 12 hours of fasting.;Lipid profile. Timepoint: at baseline and at the end of 3 months after intervention. Method of measurement: using blood testing and laboratory enzymatic methods.;Drug-related adverse events. Timepoint: monthly during the study and at the end of 3 months after intervention. Method of measurement: based on medical history, clinical examination, and patient self-report. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Javad Ehsani Ardakani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed