Several studies have shown that elevated plasma FGF21 levels are

Several studies have shown that elevated plasma FGF21 levels are found in subjects with disorders related to obesity and insulin

resistance. We aimed to assess the role of FGF21 as a potential biomarker for the diagnosis of NAFLD and/or NASH. Methods: We recruited 204 patients with and 24 without NAFLD (51 ±1 vs.50±3 years [p=0.69], male: 72% vs.58% PI3K Inhibitor Library research buy [p=0.24], 34.1 ±0.3 vs.29.3±1.0 kg/m2 [p<0.01]) and measured: 1)plasma FGF21 and cytokeratin-18 fragments (CK-18) levels, 2) liver fat by magnetic resonance imaging and spectroscopy (MRS), 3) hepatic insulin resistance index (HIRi=fasting plasma insulin x endogenous glucose production) and adipose EX 527 molecular weight tissue insulin resistance index (ATIR= fasting plasma insulin x free fatty acids), 4) muscle insulin sensitivity (Rd) during a high-dose insulin euglycemic clamp, and 5) liver histology (biopsy) (n=159). Results: Plasma levels of FGF21 were significantly

increased in patients with NAFLD (337 [217-526] vs.153 [92-323] pg/ml, p<0.001). However, FGF21 only showed moderate correlations with liver fat (r=0.26, p<0.001), HIRi (r=0.26, p=0.002), ATIR (r=0.23, p<0.001) and Rd (r=-0.35, p<0.0001). As a stand-alone test for the diagnosis of NAFLD, FGF21 had rather disappointing results. With the optimal cut-off point of 205 pg/ml we obtained a sensitivity of 78% (71-84%) and specificity of 63% (41一81%). Positive and negative predictive values were 94% (89-97%) and 28% (17-42%),

respectively. Patients with NASH had higher levels of FGF21 when compared to patients with simple steatosis on liver biopsy (386 [252-581] vs.328 [170—451] pg/ml, p=0.03). However, correlations between check details FGF21 and NAFLD activity score (r=0.22, p<0.01) and fibrosis stage (r=0.30, p<0.001) were weak. As a tool for the diagnosis of NASH (optimal cut-off point: 376 pg/ml), FGF21 also showed unsatisfactory results, with low sensitivity (53% [43 62%]) and specificity (67% [50 一 81%]). With the combined use of CK-18 and FGF21 for the diagnosis of NASH, sensitivity improved slightly to 57% (49-66%) and specificity to 85% (70-94%). However, these results were similar to the ones of CK-18 alone (sensitivity 46% [38-53%] and specificity 86% [73-95%]). Conclusions: Plasma FGF21 levels were only moderately correlated with different measures of insulin resistance, hepatic steatosis and liver histology. Based on these findings, FGF21 is not a useful stand-alone test (or combined with CK-18) for the diagnosis of NAFLD or NASH.

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