Metabolic dysfunction–associated steatotic liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH), hepatic steatosis, liver fibrosis, metabolic dysfunction Digestive System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18–65 years 2. Diagnosis of metabolic dysfunction–associated steatotic liver disease (MASLD) or metabolic dysfunction–associated steatohepatitis (MASH) 3. Evidence of hepatic steatosis defined by: 4. Imaging (ultrasonography) and/or FibroScan® controlled attenuation parameter (CAP) =248 dB/m 5. Presence of at least one metabolic risk factor (e.g. overweight/obesity, type 2 diabetes, dyslipidaemia, hypertension) 6. For MASH: elevated aminotransferases with concordant FibroScan® liver stiffness measurement (LSM) =8 kPa 7. Ability and willingness to provide written informed consent 8. Willingness to participate in longitudinal follow-up
Exclusion criteria
Exclusion criteria: 1. Chronic viral hepatitis (hepatitis B or C) 2. Autoimmune liver disease or cholestatic liver disease 3. Genetic or metabolic liver diseases (e.g. hemochromatosis, Wilson disease) 4. Drug-induced liver injury or use of known hepatotoxic medications 5. Decompensated cirrhosis or clinical evidence of portal hypertension 6. Active malignancy 7. Pregnancy or breastfeeding 8. Severe or unstable cardiovascular disease 9. Acute systemic illness at the time of enrollment 10. Significant alcohol intake 11. Inability to comply with follow-up or lifestyle intervention protocols 12. Prior bariatric surgery or planned bariatric surgery during the study period
Countries
Egypt, India, Jordan, Philippines, Saudi Arabia, Tunisia