In 2019, the ADA recommended screening for NASH and liver fibrosis in patients with T2DM and steatosis or elevated ALT. However, the true prevalence of liver fibrosis in unselected patients with T2DM in the United States remains unknown. To this end, we screened patients with T2DM attending either internal medicine (IM), family medicine (FM) or endocrinology (E) clinics unaware of having NAFLD. Screening for fibrosis (1º outcome) was done by vibration-controlled transient elastography (VCTE) and steatosis by controlled attenuation parameter (CAP) (2º outcome). We also measured diagnostic panels of fibrosis (APRI and FIB-4). A liver biopsy was done based on pre-established imaging/panel parameters if suggestive of significant fibrosis (F≥2). A total of 527 patients (IM: 112; FM: 255; E: 160) were recruited (age 60±12; 55% females; 58% non-Hispanic whites, 29% AA, 4% Asian; BMI 33±6 Kg/m2; A1c 7.5±1.7%; AST 22±10 U/L; ALT 24±17 U/L). Only 10% of patients had an ALT >40 IU/L. The prevalence of NAFLD by CAP (≥280 dB/m) was 66% with only 14% having an ALT >40 IU/L. The prevalence of fibrosis was 23% (kPa ≥7.0). In 74% of patients with liver fibrosis AST/ALT were <40 IU/L. Diagnostic panels (APRI, FIB-4) were normal in ∼50% of patients and in the “indeterminate zone” in 36%, highlighting the value of combining them with imaging when screening. Steatosis was similar across E, IM and FM clinics, but F2-3 fibrosis was more common in E than in IM and FM clinics (30 vs. 16 and 21%, respectively; both p<0.05). BMI correlated strongly with steatosis (r = 0.43) and with fibrosis (r = 0.25; both p<0.001), but glycemic control (A1c) did not correlate with either.
In conclusion, NAFLD requires greater awareness among clinicians as there is a high prevalence of undiagnosed liver steatosis and fibrosis in patients with T2DM. An approach based on ALT alone is inadequate, but a combination of diagnostic panels plus imaging is promising and deserves further exploration.
R. Lomonaco: None. N. Fanous: None. S. Kalavalapalli: None. L.J. Tejera: None. A. McCauley: None. E. Godinez: None. L. Mansour: None. S. Shrestha: None. J.S. Marte: None. J. Fakhry: None. H. Wang: None. D. Barb: None. F. Bril: None. K. Cusi: Consultant; Self; Allergan plc., AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., Gilead Sciences, Inc., Merck & Co., Inc. Research Support; Self; Cirius Therapeutics, Echosens, Eli Lilly and Company, Inventiva Pharma, Janssen Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Poxel SA, Zydus Pharmaceuticals, Inc.