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Clinical Trial
. 2020 Dec;37(12):4866-4876.
doi: 10.1007/s12325-020-01503-x. Epub 2020 Oct 1.

Clinical Characteristics of a Non-Alcoholic Fatty Liver Disease Population Across the Fibrosis Spectrum Measured by Magnetic Resonance Elastography: Analysis of Screening Data

Affiliations
Clinical Trial

Clinical Characteristics of a Non-Alcoholic Fatty Liver Disease Population Across the Fibrosis Spectrum Measured by Magnetic Resonance Elastography: Analysis of Screening Data

Grit Andersen et al. Adv Ther. 2020 Dec.

Abstract

Introduction: Non-alcoholic fatty liver disease (NAFLD), one of the most common liver diseases, is associated with liver-related complications and metabolic comorbidities. The phenotype is wide, ranging from simple steatosis to non-alcoholic steatohepatitis with advanced fibrosis. In this analysis of a phase 1 trial, clinical characteristics of screened subjects with NAFLD were studied according to the extent of fibrosis assessed using magnetic resonance elastography (MRE).

Methods: One hundred ninety-four subjects with body mass index (BMI) of 25-40 kg/m2 and suspected NAFLD were assessed by MRE and grouped by MRE thresholds as a proxy for fibrosis staging (groups 0-4). Data were summarized by group levels, and correlation analyses between MRE values and clinical parameters (including magnetic resonance imaging-proton density fat fraction) were performed.

Results: Most subjects had MRE values in the lower range (groups 0-1; N = 148). Type 2 diabetes (T2D) and BMI > 35 kg/m2 were more frequent in groups with higher than lower MRE values. Subjects in the highest MRE groups also tended to be older and have higher liver enzyme concentrations compared with lower MRE groups. No, or weak, correlations were found between MRE values and clinical parameters (all r values ≤ 0.45).

Conclusions: There was considerable variation and overlap in clinical characteristics across the spectrum of liver stiffness. Although groups with high MRE values generally included more subjects with T2D and obesity, and had higher age and concentrations of liver enzymes, the clinical characteristics did not strongly correlate with MRE scores in this population.

Trial registration: Registered on Clinicaltrials.gov on November 29, 2017 (NCT03357380).

Keywords: Fibrosis; Magnetic resonance elastography; Non-alcoholic fatty liver disease.

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Figures

Fig. 1
Fig. 1
Scatter plots of age (a), BMI (b), ALT (c), AST (d), HbA1c (e), GGT (f), NFS (g), FIB-4 (h), and MRI-PDFF (i) versus MRE values, and by presence/absence of T2D. ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, FIB-4 fibrosis-4 score, GGT gamma-glutamyl transferase, HbA1c glycated hemoglobin, MRE magnetic resonance elastography, MRI-PDFF magnetic resonance imaging-proton density fat fraction, NFS non-alcoholic fatty liver disease fibrosis score, T2D type 2 diabetes

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