Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT07663188

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionMASLD

Full registry criteria

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).

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Accuracy of current FIB-4 cut-offs in directing obese patients to FibroScan for the diagnosis of liver fibrosisAt 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.

Study locations

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No public site location was included in this record. Check the original registry for updates.