FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients

N/ANot Yet RecruitingNCT07663188

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis400 enrolled

Overview

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.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a frequent complication of metabolic syndrome and obesity and may progress to advanced fibrosis, cirrhosis and hepatocellular carcinoma. Recent EASL-EASD-EASO guidelines recommend the use of the FIB-4 score as a first-line non-invasive tool to stratify the risk of advanced fibrosis in patients with metabolic risk factors, including those with obesity. However, current FIB-4 cut-offs may lead to a high number of positive cases and an important burden of further liver stiffness assessment. This study will prospectively enroll obese patients referred to the Clinical Nutrition Center for the Research and Care of Obesity and Metabolic Diseases at IRCCS "Saverio de Bellis". During a Day Service access, patients undergo routine blood tests and FibroScan; FIB-4 is calculated using age, AST, ALT and platelet count. Patients will be classified according to FIB-4 (≥1.3 vs \<1.3), and FIB-4 performance in predicting liver fibrosis, as assessed by liver stiffness, will be evaluated using correlation analyses, Bland-Altman plots, agreement measures and ROC curves.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

MASLD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Arm 2: patients with FIB-4 \< 1.3. Exclusion Criteria: * 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).

Outcomes

Primary Outcomes

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.

Time frame: At baseline evaluation (Day Service visit)

Central Contacts

Vincenza Di Stasi, MD

CONTACT

+39 0804994669 vincenza.distasi@irccsdebellis.it

Data from ClinicalTrials.gov

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