FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients (OBEMASLD)
Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Vincenza Di Stasi, MD
- Numéro de téléphone: +39 0804994669
- E-mail: vincenza.distasi@irccsdebellis.it
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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High FIB-4
Obese patients with FIB-4 ≥ 1.3 undergoing FibroScan as part of clinical practice.
|
|
Low FIB-4
Obese patients with FIB-4 < 1.3 undergoing FibroScan as part of clinical practice
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Accuracy of current FIB-4 cut-offs in directing obese patients to FibroScan for the diagnosis of liver fibrosis
Délai: 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.
|
At baseline evaluation (Day Service visit)
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.
- European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
- Silverii GA, Profili F, Francesconi P, Mannucci E. Fibrosis-4 score for screening of metabolic dysfunction-associated steatotic liver disease (MASLD): Data from a population-based sample in Tuscany. Nutr Metab Cardiovasc Dis. 2024 Oct;34(10):2405-2408. doi: 10.1016/j.numecd.2024.05.016. Epub 2024 May 15.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
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