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

Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07663188

Acronym

OBEMASLD

Enrollment

400

Registered

2026-06-23

Start date

2026-09-01

Completion date

2028-09-01

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MASLD

Keywords

MASLD, FIB-4

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of current FIB-4 cut-offs in directing obese patients to FibroScan for the diagnosis of liver fibrosis	At baseline evaluation (Day Service visit)	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.

Contacts

CONTACTVincenza Di Stasi, MD

vincenza.distasi@irccsdebellis.it+39 0804994669

Outcome results