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Background <p>Fibrosis-4 index (FIB-4) is a well-established non-invasive test that reliably stratifies advanced fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). However, FIB-4’s limitations include a high proportion of indeterminate results, particularly among patients with type 2 diabetes mellitus (T2DM), which necessitate further diagnostic assessments at tertiary-care centers.</p> Objective&#xa0; <p>We aimed to evaluate FIB-4’s performance as a first-line stratification tool and to explore sequential biomarkers for stratifying advanced fibrosis among MASLD patients with T2DM who have indeterminate FIB-4 results.</p> Methods <p>A cross-sectional study on 253 MASLD patients was conducted. Clinical data including T2DM status, FIB-4 index, and liver stiffness measurement using transient elastography were obtained.</p> Results <p>Nearly half of the MASLD patients with T2DM<b> (</b><i>n</i> = 65/139, 46.8%) had FIB-4 ≥ 1.3, which required further tertiary-care assessments according to our national T2DM guideline, compared to 25.4% of patients without T2DM (<i>n</i> = 29/114). More T2DM patients had indeterminate FIB-4 ≥ 1.3- &lt; 3.25 (38.8% vs. 21.9% without T2DM). Among T2DM patients with indeterminate FIB-4, gamma-glutamyl transferase (GGT) levels above the upper limit of normal showed a 8.14-fold increased risk of advanced fibrosis (odds ratio, 8.14; 95% CI, 2.41–27.52; &#xa0;<i>p</i> &lt; 0.001). Sequential use of FIB-4 followed by GGT improved stratification performance, with sensitivity increasing from 58.2% to 75.0% and specificity from 63.9% to 73.1%, while referral rates decreased from 46.8% to 28.1% (<i>n</i> = 39/139). FIB-4 ≥ 3.25 appeared to predict advanced fibrosis effectively.</p> Conclusions <p>Sequential FIB-4 followed by GGT enhances the stratification of advanced fibrosis in MASLD patients with T2DM who have indeterminate FIB-4 results, potentially reducing the need for tertiary-care referrals.</p>

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Improving stratification of advanced fibrosis in metabolic dysfunction-associated steatotic liver disease patients with type-2 diabetes mellitus in low-resource settings

  • 期刊论文

  • 发表日期：

    2026年3月10日

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  • Wei Yoon Poh,
  • Shamsul Mohd Zain,
  • Fatiha Hana Shabaruddin,
  • Amirah Azzeri,
  • Shir Ley Lee,
  • Rosmawati Mohamed

摘要

Background

Fibrosis-4 index (FIB-4) is a well-established non-invasive test that reliably stratifies advanced fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). However, FIB-4’s limitations include a high proportion of indeterminate results, particularly among patients with type 2 diabetes mellitus (T2DM), which necessitate further diagnostic assessments at tertiary-care centers.

Objective 

We aimed to evaluate FIB-4’s performance as a first-line stratification tool and to explore sequential biomarkers for stratifying advanced fibrosis among MASLD patients with T2DM who have indeterminate FIB-4 results.

Methods

A cross-sectional study on 253 MASLD patients was conducted. Clinical data including T2DM status, FIB-4 index, and liver stiffness measurement using transient elastography were obtained.

Results

Nearly half of the MASLD patients with T2DM (n = 65/139, 46.8%) had FIB-4 ≥ 1.3, which required further tertiary-care assessments according to our national T2DM guideline, compared to 25.4% of patients without T2DM (n = 29/114). More T2DM patients had indeterminate FIB-4 ≥ 1.3- < 3.25 (38.8% vs. 21.9% without T2DM). Among T2DM patients with indeterminate FIB-4, gamma-glutamyl transferase (GGT) levels above the upper limit of normal showed a 8.14-fold increased risk of advanced fibrosis (odds ratio, 8.14; 95% CI, 2.41–27.52;  p < 0.001). Sequential use of FIB-4 followed by GGT improved stratification performance, with sensitivity increasing from 58.2% to 75.0% and specificity from 63.9% to 73.1%, while referral rates decreased from 46.8% to 28.1% (n = 39/139). FIB-4 ≥ 3.25 appeared to predict advanced fibrosis effectively.

Conclusions

Sequential FIB-4 followed by GGT enhances the stratification of advanced fibrosis in MASLD patients with T2DM who have indeterminate FIB-4 results, potentially reducing the need for tertiary-care referrals.