1. Performance of the SteatoTest, ActiTest, NashTest and FibroTest in a multiethnic cohort of patients with type 2 diabetes mellitus
- Author
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Kenneth Cusi, Thierry Poynard, Virginia Clark, Jean-Marie Castille, Michael P. Caulfield, Fernando Bril, Jinping Lai, Roberto J. Firpi-Morell, Consuelo Soldevila-Pico, and Michael J. McPhaul
- Subjects
Liver Cirrhosis ,Male ,insulin ,030213 general clinical medicine ,medicine.medical_specialty ,030204 cardiovascular system & hematology ,Gastroenterology ,General Biochemistry, Genetics and Molecular Biology ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Non-alcoholic Fatty Liver Disease ,Internal medicine ,Diabetes mellitus ,Ethnicity ,medicine ,Humans ,hepatitis ,Diagnostic Techniques and Procedures ,Original Research ,fatty liver ,Inflammation ,Hepatitis ,Receiver operating characteristic ,FibroTest ,business.industry ,Fatty liver ,nutritional and metabolic diseases ,General Medicine ,Middle Aged ,medicine.disease ,Diabetes Mellitus, Type 2 ,diabetes mellitus ,Biomarker (medicine) ,Female ,Steatosis ,Steatohepatitis ,business ,Biomarkers - Abstract
Fibromax is a diagnostic tool composed of the combination of 4 non-invasive biomarker panels for the diagnosis of steatosis (SteatoTest), necrosis and inflammation (ActiTest and NashTest-2) and fibrosis (FibroTest). The purpose of this study was to assess the performance of these biomarker panels in patients with type 2 diabetes mellitus (T2DM). All patients underwent routine labs, a 75 g oral glucose tolerance test, a liver proton magnetic resonance spectroscopy (1H-MRS) to measure intrahepatic triglyceride content, and a percutaneous liver biopsy to establish the diagnosis of non-alcoholic steatohepatitis (NASH) and to grade and stage the disease in those patients with non-alcoholic fatty liver disease (NAFLD) by 1H-MRS. For determination of the scores, plasma samples were blindly provided to establish the SteatoTest, ActiTest, NashTest-2 and FibroTest scores. A total of 220 patients with T2DM were included in this study. When the ability of the SteatoTest to identify patients with T2DM with NAFLD by 1H-MRS was assessed, the overall performance expressed as the area under the receiver operating characteristic curve was 0.73 (95% CI 0.65 to 0.81). The performance of the ActiTest and NashTest-2 to diagnose definite NASH among patients with T2DM was 0.70 (95% CI 0.63 to 0.77) and 0.69 (95% CI 0.62 to 0.76), respectively. Regarding the FibroTest score, its performance to identify patients with moderate or advanced fibrosis was 0.67 (95% CI 0.58 to 0.76) and 0.72 (95% CI 0.61 to 0.83), respectively. Non-invasive panels for the diagnosis of steatosis, NASH and/or fibrosis, which were developed and validated in non-diabetic cohorts, underperformed when applied to a large cohort of patients with T2DM. Results from non-diabetic populations should not be extrapolated to patients with T2DM.
- Published
- 2019
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