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

Authors

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

Published in

BMC endocrine disorders. Jul 20, 2026. Epub Jul 20, 2026.

Abstract

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.
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.
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).
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.
Not applicable.

PMID:
42477634
Bibliographic data and abstract were imported from PubMed on 21 Jul 2026.

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