Two-tier screening approach for liver fibrosis stratification in outpatients with type 2 diabetes mellitus: A multicenter cross-sectional study

Background: To examine the prevalence and severity of metabolic dysfunction-associated steatotic liver disease (MASLD) in outpatients with type 2 diabetes mellitus (T2DM), and to assess the effectiveness of the EASL-EASD-EASO algorithm for liver fibrosis screening. Methods: We retrospectively enrolled 1203 Italian older outpatients with T2DM who underwent vibration-controlled transient elastography (VCTE) with liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) assessment. MASLD was defined as CAP ≥248 dB/m. Significant liver fibrosis was defined as LSM ≥8 kPa, compensated advanced chronic liver disease (cACLD) as LSM ≥10 kPa, and clinically significant portal hypertension (CSPH) as LSM ≥25 kPa or LSM ≥20 kPa and platelet count <150 000/mm3. FIB-4 index was calculated in all participants. Results: The prevalence rates of MASLD, significant liver fibrosis, cACLD, and CSPH were 71.3%, 21.1%, 11.7% and 1.7%, respectively. A 2-tier screening strategy for liver fibrosis using the FIB-4 index and VCTE showed that among patients with a normal FIB-4 index, 629 (83.3%) had LSM <8 kPa and 126 (16.7%) had LSM≥8 kPa. Sensitivity, specificity, NPV, and PPV of the FIB-4 index for detecting LSM≥8 kPa were 50.4%, 66.3%, 83.3% and 28.6%, respectively. Increased body weight (adjusted-OR 3.34, 95%CI 1.75–6.39) and elevated ALT levels (adjusted-OR 1.54, 95%CI 1.01–2.36) were the strongest predictors of significant liver fibrosis. Conclusions: MASLD and significant liver fibrosis are common in older patients with T2DM. Fibrosis risk stratification using FIB-4, followed by VCTE, is a good strategy in real-world settings. However, relying solely on FIB-4 may fail to identify some patients with advanced disease, particularly those with increased body weight and elevated serum aminotransferase levels.