High Prevalence of NASH and Advanced Fibrosis in Type 2 Diabetes: A Prospective Study of 330 Outpatients Undergoing Liver Biopsies for Elevated ALT, Using a Low Threshold

   OBJECTIVE Most people with type 2 diabetes (T2DM) and nonalcoholic steatohepatitis (NASH) or advanced fibrosis remain undiagnosed, resulting in missed opportunities for early intervention. This multicenter prospective study aimed at assessing the yield of using routinely available data for identifying these patients. RESEARCH DESIGN AND METHODS A total of 713 outpatients with T2DM, screened in four diabetology clinics for nonalcoholic fatty liver disease (NAFLD) according to American Diabetes Association criteria, were referred to hepatologists for further work-up (FIB-4 and vibration controlled transient elastography (VCTE)). A liver biopsy was proposed when ALT levels were persistently >20 IU/L in females or >30 IU/L in males, in the absence of other liver disease. RESULTS Liver biopsies were performed in 360 patients and considered adequate for reading after central review in 330 (median age 59 years, male 63%, BMI 32 kg/m2, HbA1C 7.5 %). Prevalence of NASH, advanced fibrosis, and cirrhosis were 58%, 38%, and 10%, respectively. Liver lesions were independently associated with the components of metabolic syndrome, but not with the micro- and macrovascular complications of T2DM. Models based on routinely available data with or without VCTE had good accuracy to predict advanced fibrosis (AUROC 0.84 and 0.77, correctly classified 59% and 45%, respectively) and NASH (AUROC 0.82 and 0.81, 44% and 42%, respectively).  CONCLUSIONS Despite the use of a low ALT threshold, prevalence of NASH (58%) or advanced fibrosis (38%) was high. Routinely available data had a high yield in identifying T2DM patients with advanced fibrosis and/or NASH requiring further liver assessment.</p