Condition 1: Non-Alcoholic Fatty Liver Disease (NAFLD). Condition 2: Type 2 Diabetes Mellitus (T2DM). Liver disorders in diseases classified elsewhere Diabetes mellitus due to underlying condition
Conditions
Interventions
Intervention 1: Intervention Group : Patients in this group will receive 10 mg of Empagliflozin (oral tablet) daily, manufactured by Abidi Pharmaceutical Company. This medication will be administered
Sponsors
Bandare-abbas University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Age of participants: Minimum 20 years old. Diagnosis of hepatic steatosis (fatty liver): Confirmed through ultrasound or other methods. Type 2 diabetes mellitus: HbA1c between 7.0% and 10.0%. Informed written consent: Participants must provide informed and written consent to participate in the study.
Exclusion criteria
Exclusion criteria: History of chronic liver diseases such as cirrhosis or hepatitis B and C. Use of medications affecting the liver, such as oral contraceptives, glucocorticoids, or sports supplements. History of liver cancer or other types of cancer. Drug abuse or substance dependency. Chronic kidney disease with significantly reduced function. Pregnancy or breastfeeding. Incomplete or missing patient data. Use of medications affecting hemostasis or blood factors, such as antiplatelet agents or oral anticoagulants. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Liver Fat Grade Description: The liver fat grade (NAFLD) of patients will be assessed before and after the intervention using ultrasound. Change in Liver Enzymes (ALT, AST, GGT)Description: The mean serum levels of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-Glutamyl Transferase (GGT) will be measured and analyzed for changes. Change in Non-Invasive Liver Fibrosis Indices (FIB-4, APRI, Forns Index)Description: These non-invasive indices will be used to evaluate liver fibrosis, and their changes will be compared. Change in Body Weight and BMI Description: The mean body weight and Body Mass Index (BMI) of patients will be analyzed before and after the intervention. Change in Fasting Blood Sugar (FBS) and HbA1c Levels Description: Fasting blood sugar and Hemoglobin A1c (HbA1c) levels will be assessed as indicators of glycemic control. Timepoint: Baseline Measurement (Before the Start of Intervention): Assessment and recording of liver fat grade, liver enzymes, non-invasive liver fibrosis indices, body weight, BMI, fasting blood sugar (FBS), and HbA1c.Measurement at Week 8 Post-Intervention: Re-assessment of the mentioned parameters to evaluate initial changes. Measurement at Week 20 Post-Intervention: Re-assessment to evaluate mid-term changes. Final Measurement at the End of the Study (6 Months Post-Intervention): Final comparison of data to determine the impact of the intervention. Method of measurement: Liver Fat Grade:Measurement Method: Assessment using an ESAOTE ultrasound machine with a 3.5 MHz probe to evaluate liver fat grade.Liver Enzymes (Alanine Aminotransferase, Aspartate Aminotransferase, Gamma-Glutamyl Transferase):Measurement Method: Blood tests using standard laboratory kits and a spectrophotometer device.Non-Invasive Liver Fibrosis Indices (FIB-4 Index, APRI Index, Forns Index):Measurement Method: Calculations based on age, platelet count, liver enzymes, and cholesterol levels using the standard formulas for e | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAbdolrasoul Tavakoli
Bandare-abbas University of Medical Sciences
Outcome results
None listed