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).
Consecutive adult obese patients (BMI ≥ 30 and ≤ 40 kg/m²), aged 18-64 years, attending the outpatient Clinical Nutrition Center for the Research and Care of Obesity and Metabolic Diseases at IRCCS "Saverio de Bellis" (Castellana Grotte, Italy). Patients are enrolled during a Day Service access in which routine blood tests and liver stiffness measurement by FibroScan are performed as part of standard clinical practice. Patients are stratified into two cohorts based on FIB-4 score: Cohort 1 (FIB-4 ≥ 1.3) and Cohort 2 (FIB-4 \< 1.3). Patients with known liver diseases other than MASLD, pregnancy, or current treatment with GLP-1 receptor agonists known to affect hepatic steatosis (Semaglutide or Tirzepatide) are excluded
Cohort
Prospective
Not listed
Accuracy of current FIB-4 cut-offs in directing obese patients to FibroScan for the diagnosis of liver fibrosis
Diagnostic accuracy (sensitivity, specificity, predictive values, ROC-AUC) of FIB-4 thresholds (e.g. 1.3) for the prediction of liver fibrosis as defined by liver stiffness measurements obtained by FibroScan.
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