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. 2025 Apr 14.
doi: 10.14309/ajg.0000000000003493. Online ahead of print.

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

Gian Paolo Caviglia  1 , Arianna Ferro  1 , Roberta D'Ambrosio  2 , Riccardo Perbellini  2 , Pietro Lampertico  2   3 , Giulia Periti  4 , Luca Valenti  4   5 , Carlo Ciccioli  6 , Grazia Pennisi  6 , Salvatore Petta  6 , Lucia Brodosi  7   8 , Maria Letizia Petroni  7   8 , Francesca Marchignoli  7   8 , Loris Pironi  7   8 , Alessandra Sagripanti  9 , Maria Eva Argenziano  9 , Gianluca Svegliati-Baroni  9 , Chiara Rosso  1 , Federica Barutta  1 , Angelo Armandi  1   10 , Gabriella Gruden  1 , Elisabetta Bugianesi  1
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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

Gian Paolo Caviglia et al. Am J Gastroenterol. .

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.

Keywords: MASH; MASLD; T2DM; elastography; noninvasive.

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