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Background &amp; Aims <p>Cirrhosis remains a leading cause of liver-related morbidity and mortality and is often diagnosed only at advanced stages. Individuals with type 2 diabetes mellitus (T2DM) are at increased risk, yet systematic screening for early fibrosis is rarely implemented. We evaluated whether the Fibrosis-4 (FIB-4) index, a widely used non-invasive biomarker, can identify elevated cirrhosis risk near the time of T2DM diagnosis.</p> Methods <p>We conducted a retrospective cohort study using the NIH <i>All of Us</i> Research Program database. Adults with newly diagnosed T2DM and laboratory data for FIB-4 calculation within ± 365 days of diagnosis were included. Cases were participants who subsequently developed cirrhosis; controls were those who did not. FIB-4 distributions were compared using Wilcoxon rank-sum tests. Cox proportional hazards models assessed the association between FIB-4 and time to cirrhosis. Discriminative ability was evaluated using receiver operating characteristic (ROC) analysis, and Kaplan–Meier curves compared time-to-event outcomes by FIB-4 category.</p> Results <p>Among 9,253 participants (136 cases, 9,117 controls), median FIB-4 was higher in cases (1.38; 95% CI: 1.25–1.48) than controls (1.00; 95% CI: 0.99–1.01; <i>p</i> &lt; 0.001). Higher FIB-4 was associated with increased cirrhosis risk in Cox regression analyses (adjusted HR = 1.16 per 1‑unit increase; 95% CI 1.08–1.24; <i>p</i> &lt; 0.001). ROC analysis yielded an AUROC of 0.66, indicating moderate discriminative ability, with an optimal cutoff of 1.23 derived for internal stratification. Kaplan–Meier analysis showed shorter time to cirrhosis for FIB-4 ≥ 1.23 (log-rank <i>p</i> &lt; 0.001).</p> Conclusions <p>FIB-4 measured near T2DM diagnosis may serve as an early signal for cirrhosis risk. Incorporating FIB-4 into diabetes care pathways could enable timely referral and intervention, improving long-term liver outcomes.</p> Clinical trial number <p>Not applicable.</p>

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Early identification of cirrhosis risk in type 2 diabetes using the Fibrosis-4 index: evidence from a large U.S. cohort

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月20日

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  • Mark W. McGiffin,
  • Patrick J. Kiel,
  • David R. Foster,
  • Kevin J. Mumford,
  • Gregory H. Palmrose,
  • Michael A. Preston

摘要

Background & Aims

Cirrhosis remains a leading cause of liver-related morbidity and mortality and is often diagnosed only at advanced stages. Individuals with type 2 diabetes mellitus (T2DM) are at increased risk, yet systematic screening for early fibrosis is rarely implemented. We evaluated whether the Fibrosis-4 (FIB-4) index, a widely used non-invasive biomarker, can identify elevated cirrhosis risk near the time of T2DM diagnosis.

Methods

We conducted a retrospective cohort study using the NIH All of Us Research Program database. Adults with newly diagnosed T2DM and laboratory data for FIB-4 calculation within ± 365 days of diagnosis were included. Cases were participants who subsequently developed cirrhosis; controls were those who did not. FIB-4 distributions were compared using Wilcoxon rank-sum tests. Cox proportional hazards models assessed the association between FIB-4 and time to cirrhosis. Discriminative ability was evaluated using receiver operating characteristic (ROC) analysis, and Kaplan–Meier curves compared time-to-event outcomes by FIB-4 category.

Results

Among 9,253 participants (136 cases, 9,117 controls), median FIB-4 was higher in cases (1.38; 95% CI: 1.25–1.48) than controls (1.00; 95% CI: 0.99–1.01; p < 0.001). Higher FIB-4 was associated with increased cirrhosis risk in Cox regression analyses (adjusted HR = 1.16 per 1‑unit increase; 95% CI 1.08–1.24; p < 0.001). ROC analysis yielded an AUROC of 0.66, indicating moderate discriminative ability, with an optimal cutoff of 1.23 derived for internal stratification. Kaplan–Meier analysis showed shorter time to cirrhosis for FIB-4 ≥ 1.23 (log-rank p < 0.001).

Conclusions

FIB-4 measured near T2DM diagnosis may serve as an early signal for cirrhosis risk. Incorporating FIB-4 into diabetes care pathways could enable timely referral and intervention, improving long-term liver outcomes.

Clinical trial number

Not applicable.