This single-center, prospective observational study aims to assess the accuracy of FIB-4 cut-offs in identifying liver fibrosis in obese patients attending an endocrinology outpatient clinic in Italy.
All consecutive eligible patients undergo routine blood tests and liver elastography (FibroScan) as part of clinical practice; FIB-4 values will be calculated and compared with liver stiffness measurements to evaluate the performance of FIB-4 thresholds for directing patients to FibroScan and hepatology care.
Obesity class I or II (body mass index, BMI ≥ 30 kg/m² and ≤ 40 kg/m²)
Age > 18 years and < 65 years.
Ability to provide written informed consent after adequate information on the study objectives.
Arm 1: patients with FIB-4 ≥ 1.3.
Lack of signed informed consent.
Pregnancy or breastfeeding.
Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis).
Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead sponsor