Poster Author of 2 e-Posters
SE-071 - Serum ferritin levels in patients with non-elevated proton-density fat fraction-derived R2* liver iron concentration – an exploratory study of Revita-2 phase II trial data
SE-072 - MRI liver proton density fat fraction in patients with type 2 diabetes mellitus following treatment with Duodenal Mucosal Resurfacing – results from a randomised, double-blind, sham-controlled, prospective, multicentre study
Author of 2 Presentations
SE-071 - Serum ferritin levels in patients with non-elevated proton-density fat fraction-derived R2* liver iron concentration – an exploratory study of Revita-2 phase II trial data
Abstract
Purpose
Dysregulation of iron homeostasis has been associated with fatty liver disease and type 2 diabetes mellitus (T2DM). Serum ferritin levels are positively correlated with elevated liver iron concentration (LIC), but the relationship in patients with non-elevated liver iron concentration (LIC) is not known. Here, we investigate the relationship between serum ferritin levels and non-elevated proton-density fat fraction (PDFF) derived R2* liver iron concentration (LIC) in patients with T2DM undergoing endoscopic Duodenal Mucosal Resurfacing (DMR) in the Revita-2 trial.
Material and methods
Revita-2 is a phase II blinded, sham-controlled international multi-site multi-scanner vendor cross-over trial (NCT02879383). Average LIC measurements were obtained from vendor-derived PDFF R2* maps from seven sites (TR=5-10ms, TE of first echo=1-2ms, number of echoes=6, alpha=3 degrees, 6mm slice thickness, 2-2.5 mm isotropic inplane resolution), with circular regions-of-interest (ROIs) placed in each of the 9 Coinaud liver segments. Baseline and 12-week post-treatment liver MRI scans with paired serum ferritin levels for initial open-label training (n=17), DMR (n=39) and sham (n=23) cohorts were analysed.
Results
At baseline, a modest positive but significant correlation was demonstrated between LIC and serum ferritin (r=0.5313, P<0.0001). Following treatment, change in LIC and serum ferritin were poorly correlated across all three cohorts (training r=0.3683, P=NS; DMR r=0.1075, P=NS; sham r=-0.1319, P=NS).
Conclusion
Even at non-elevated LIC levels, serum ferritin and LIC are positively correlated. Poor post-treatment change in LIC and serum ferritin correlations may reflect mechanistic effects on hepatic iron metabolism as a result of DMR.
SE-072 - MRI liver proton density fat fraction in patients with type 2 diabetes mellitus following treatment with Duodenal Mucosal Resurfacing – results from a randomised, double-blind, sham-controlled, prospective, multicentre study
Abstract
Purpose
To investigate the effects of endoscopic Duodenal Mucosal Resurfacing (DMR) in patients with sub-optimally controlled type 2 diabetes mellitus (T2DM) on liver fat fraction (FF) using MRI proton density fat fraction (PDFF).
Material and methods
Revita-2 is a phase II blinded, sham-controlled international multi-site multi-scanner vendor cross-over trial (NCT02879383). Average FF measurements were obtained from vendor-derived PDFF maps from seven sites (TR=5-10ms, TE of first echo=1-2ms, number of echoes=6, alpha=3 degrees, 6mm slice thickness, 2-2.5 mm isotropic inplane resolution), with circular regions-of-interest (ROIs) placed in each of the 9 Coinaud liver segments. Baseline and 12-week post-treatment FF data in patients with baseline hepatic steatosis (average FF>5%), randomised to DMR or sham treatment were analysed. Longitudinal measurement stability was confirmed using custom-built fat-water liquid-emulsion based phantoms.
Results
A total of 108 patients were enrolled (DMR n=56, sham n=52). Prespecified interaction testing revealed non-homogeneity between one country and the remaining patient populations – analyses were therefore stratified. From the remaining patient population, baseline hepatic steatosis (n=60) was prevalent in both cohorts (DMR n=33 (85%) vs sham n=27 (75%), P=0.250), mean liver FF 16.5% (DMR) vs 16.1% (sham, P=0.500). Median change in liver FF from baseline at 12 weeks was -5.4% (DMR) vs -2.4% (sham, P=0.039, absolute difference) and -32.1% (DMR) vs -18.1% (sham, P=0.025, relative difference).
Conclusion
DMR elicits favourable effects on liver PDFF at 12 weeks, in patients with sub-optimally controlled T2DM.