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

NCT07663188 | Not Yet Recruiting

• 1 other identifier: RC2026-31
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

MASLD

Keywords

MASLD; FIB-4

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline evaluation (Day Service visit)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Related Publications (3)

• 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.

  PMID: 38890093 BACKGROUND

• 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.

  PMID: 38851997 BACKGROUND

• 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.

  PMID: 37364790 BACKGROUND

Central Study Contacts

Vincenza Di Stasi, MD

CONTACT

+39 0804994669; vincenza.distasi@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share