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

Diabetes Obes Metab. 2026 Jan;28(1):644-653. doi: 10.1111/dom.70245. Epub 2025 Nov 2.

Abstract

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.

Keywords: CAP; FIB4; Fibroscan; MASLD; T2DM; diabetes mellitus; fibrosis; hepatic steatosis; metabolic dysfunction‐associated steatotic liver disease; type 2 diabetes.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Algorithms
  • Cross-Sectional Studies
  • Diabetes Mellitus, Type 2* / complications
  • Diabetes Mellitus, Type 2* / epidemiology
  • Elasticity Imaging Techniques
  • Fatty Liver* / diagnosis
  • Fatty Liver* / epidemiology
  • Female
  • Humans
  • Italy / epidemiology
  • Liver Cirrhosis* / diagnosis
  • Liver Cirrhosis* / diagnostic imaging
  • Liver Cirrhosis* / epidemiology
  • Liver Cirrhosis* / etiology
  • Male
  • Mass Screening* / methods
  • Middle Aged
  • Outpatients
  • Prevalence
  • Retrospective Studies
  • Severity of Illness Index

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