FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: MASLD. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy
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.
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.
Primary outcome measures
- Accuracy of current FIB-4 cut-offs in directing obese patients to FibroScan for the diagnosis of liver fibrosis [Time frame: At baseline evaluation (Day Service visit)]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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, Mo PMID 37364790
Identifiers
NCT: NCT07663188 · RC2026-31