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