American Diabetes Association
DC20_1997_Online-Only_Supplemental_Material-1.pdf (101.39 kB)

Advanced Liver Fibrosis Is Common in Patients With Type 2 Diabetes Followed in the Outpatient Setting: The Need for Systematic Screening

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Version 2 2021-01-11, 09:12
Version 1 2020-12-21, 18:24
posted on 2021-01-11, 09:12 authored by Romina Lomonaco, Eddison Godinez Leiva, Fernando Bril, Sulav Shrestha, Lydia Mansour, Jeff Budd, Jessica Portillo Romero, Siegfried Schmidt, Ku-Lang Chang, George Samraj, John Malaty, Katherine Huber, Pierre Bedossa, Srilaxmi Kalavalapalli, Jonathan Marte, Diana Barb, Danielle Poulton, Nada Fanous, Kenneth Cusi
Objective: Assess the prevalence of NAFLD and of liver fibrosis associated with nonalcoholic steatohepatitis (NASH) in unselected patients with T2DM.

Research Design and Methods: 561 patients with T2DM (age: 60±11; BMI: 33.4±6.2 kg/m2; HbA1c: 7.5±1.8%) attending primary care or endocrinology outpatient clinics and unaware of having NAFLD. At the visit, volunteers were invited to be screened by elastography for steatosis and fibrosis by CAP (≥274 dB/m) and LSM (≥7.0 kPa), respectively. Secondary causes of liver disease were ruled out. Diagnostic panels for prediction of advanced fibrosis, such as APRI and FIB-4, were also measured. A liver biopsy was performed if results were suggestive of fibrosis.

Results: The prevalence of steatosis was 70% and of fibrosis 21% (LSM≥7.0 kPa). Moderate fibrosis (F2: LSM≥8.2 kPa) was present in 6% and severe fibrosis or cirrhosis (F3-4: LSM≥9.7 kPa) in 9%, similar to that estimated by FIB-4 and APRI panels. Non-invasive testing was consistent with liver biopsy results. Elevated AST or ALT ≥40 U/L were present in a minority of patients with steatosis (8% and 13%, respectively) or with liver fibrosis (18% and 28%, respectively). This suggests that AST/ALT alone are insufficient as initial screening. However, performance may be enhanced by imaging (e.g., transient elastography) and plasma diagnostic panels (e.g., FIB-4, APRI).

Conclusions: Moderate-to-advanced fibrosis (F≥2), an established risk factor for cirrhosis and overall mortality, affects at least one-out-of-six (15%) patients with T2DM. These results support the ADA guidelines to screen for clinically significant fibrosis in patients with T2DM with steatosis or elevated ALT.


This study was funded in part by Echosens (Paris, France).