Effectiveness of a Model of Care Based on Fibrosis-4 and Liver Stiffness Measurement for the Screening of Patients With Type 2 Diabetes Mellitus at Risk of Advanced Liver Disease: Results From an Italian Prospective Multicenter Study
Year: 2025
Type: article
Study design: Observational Study
Abstract: INTRODUCTION: Patients with type 2 diabetes mellitus (T2DM) are at increased risk of metabolic dysfunction-associated steatotic liver disease, advanced liver fibrosis, and metabolic dysfunction-associated steatohepatitis (MASH). We evaluated the prevalence and severity of metabolic dysfunction-associated steatotic liver disease among patients with T2DM at their first referral to diabetes clinics and assessed the effectiveness of the 2-tier screening approach by Fibrosis-4 (FIB-4) and vibration-controlled transient elastography (VCTE). METHODS: Consecutive patients with T2DM from 6 different diabetes clinics were prospectively enrolled. Liver stiffness measurement (LSM) was assessed by VCTE, whereas liver steatosis by controlled attenuation parameter (Fibroscan, Echosens, France). "At-risk MASH" was assessed by FibroScan-aspartate aminotransferase score. RESULTS: Eight hundred patients (median age: 59, 53-65 years; males: 485, 60.6%) met the inclusion criteria. Prevalence of liver steatosis (controlled attenuation parameter ≥ 248 db/m) was 73.6%. The proportion of patients at medium/high risk of advanced liver fibrosis (LSM ≥ 8.0 kPa) was 16.9%. Patients with "at-risk MASH" (FibroScan-aspartate aminotransferase > 0.67) were 12.0%. A 2-tier screening for advanced liver fibrosis by FIB-4 and VCTE would have led to 70 patients (8.8%) referred to liver clinics with a false-negative rate of 9.6% (n = 77; patients with FIB-4 < 1.3 and LSM ≥ 8.0 kPa). At multivariate analysis, overweight/obesity (odds ratio = 3.13, 95% confidence interval 1.23-7.97) and elevated alanine aminotransferase (odds ratio = 1.91, 95% confidence interval 1.17-3.10) were independently associated with LSM ≥ 8.0 kPa in patients with FIB-4 < 1.3. DISCUSSION: In diabetes clinics, the 2-tier screening using FIB-4 and VCTE is effective for the identification of patients with T2DM to be referred to hepatologists. VCTE referral may be considered for patients with overweight/obesity and elevated alanine aminotransferase classified as at low risk of advanced liver fibrosis by FIB-4.
Authors: Gian Paolo Caviglia, Arianna Ferro, Roberta D'Ambrosio, Riccardo Perbellini, Pietro Lampertico, Giulia Periti, Luca Valenti, Carlo Ciccioli, Grazia Pennisi, Salvatore Petta, Lucia Brodosi, Maria Letizia Petroni, Francesca Marchignoli, Loris Pironi, Alessandra Sagripanti, Maria Eva Argenziano, Gianluca Svegliati-Baroni, Chiara Rosso, Federica Barutta, Angelo Armandi, Gabriella Gruden, Elisabetta Bugianesi
Institutions: University of Turin, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, University of Palermo, IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, University of Bologna, Marche Polytechnic University, University Medical Center of the Johannes Gutenberg University Mainz
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: Gilead Sciences
OpenAlex ID: W4409434318