Longitudinal Validation of Clinical Care Pathways for Metabolic Dysfunction-Associated Steatotic Liver Disease in a Prospective Cohort of Individuals With Type 2 Diabetes.

Authors

Jonathan Dounel, Luis Antonio Díaz, Ricki Bettencourt, Federica Tavaglione, Egbert Madamba, Lisa Richards, Rohit Loomba, Veeral Ajmera

Published in

Gastro hep advances. Volume 5. Issue 9. Pages 101022. Epub May 27, 2026.

Abstract

The American Gastroenterological Association (AGA) Clinical Care Pathway provides a tiered, noninvasive algorithm for fibrosis risk stratification in populations at high risk for metabolic dysfunction-associated steatotic liver disease (MASLD). We assessed the 2-year longitudinal performance of the AGA pathway using magnetic resonance elastography (MRE) as the reference.
This prospective cohort study enrolled adults aged 50-79 years with type 2 diabetes mellitus from ambulatory care clinics between the dates of February 2016 and February 2025. Participants underwent a standardized clinical research visit with Fibrosis-4 index (FIB-4), vibration-controlled transient elastography (VCTE), and MRE at baseline and at a 2-year interval at the UCSD MASLD Research Center.
Of 626 participants with a baseline assessment, 209 had longitudinal follow-up assessment and were included in the study. The prevalence of MASLD was 69.9%, and 19.0% had significant fibrosis at baseline (MRE ≥3.30 kPa). Applying the AGA pathway of FIB-4 and VCTE, the false negative rate (low risk by pathway with MRE ≥3.30 kPa) at baseline was 7% with 17.6% of participants qualifying for specialty referral. At 2-year follow-up, the false negative rate decreased to 3% and an additional 7%, respectively qualified for specialty referral. Applying a FIB-4 cut point of 1.0 decreased the false negative rate to 0%; however, the number of patients requiring VCTE increased by 54% over 2-years.
Longitudinal reassessment of patients initially classified as low risk by the AGA Clinical Care Pathway substantially reduced misclassification of significant fibrosis, while maintaining a low rate of specialty referral. These findings support serial re-evaluation as a key component of noninvasive fibrosis risk stratification in at-risk populations.

PMID:
42405291
Bibliographic data and abstract were imported from PubMed on 06 Jul 2026.

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