Author information
1
Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, FL, USA.
2
Malcom Randall Veterans Administration Medical Center, Gainesville, FL, USA.
3
OWL Metabolomics, Derio, Spain.
4
Quest Diagnostics Nichols Institute, San Juan Capristano, CA, USA.
5
CIC bioGUNE, CIBERehd, Derio, Spain.
Abstract
AIMS:
While several non-invasive clinical/metabolic scores have been designed to predict the presence of nonalcoholic steatohepatitis (NASH), none was specifically validated in patients with T2DM. We aimed to assess the utility of existing metabolomics scores to classify liver disease in patients with T2DM.
MATERIALS AND METHODS:
A total of 220 patients with T2DM were recruited. Patients underwent routine lab tests, a liver proton magnetic resonance spectroscopy (1 H-MRS), a 75-gram OGTT, and a liver biopsy if they had NAFLD by 1 H-MRS. A serum sample was blindly provided to OWL Metabolomics for measurement of OWLiver® Care test and OWLiver® test.
RESULTS:
When compared to liver biopsy, OWLiver® Care and OWLiver® tests had a suboptimal performance in patients with T2DM (both AUROCs<0.70). Given the discordance of these results in this heterogeneous, multiethnic cohort compared to a prior report in predominantly Caucasian non-diabetic patients, we examined the influence of age, ethnicity and other parameters on test performance. A specific subset of patients was selected to mirror the characteristics of the population used for the development of this model (i.e., Caucasian without T2DM). Among Caucasian patients with good glycemic control (HbA1c<7.0%) and without cirrhosis, the AUROC curve was significantly improved (0.79 [0.68-0.90]). Among Caucasian patients with lower insulin resistance (HOMA-IR<3) and without cirrhosis, the AUROC was even higher: 0.87 (0.76-0.97).
CONCLUSIONS:
There is a great need to develop non-invasive approaches to diagnose NASH in patients with T2DM. However, models originally developed for patients without diabetes cannot be directly applied to patients with T2DM.