RT Journal Article
SR Electronic
T1 Post hoc analyses of surrogate markers of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis in patients with type 2 diabetes in a digitally supported continuous care intervention: an open-label, non-randomised controlled study
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e023597
DO 10.1136/bmjopen-2018-023597
VO 9
IS 2
A1 Eduardo Vilar-Gomez
A1 Shaminie J Athinarayanan
A1 Rebecca N Adams
A1 Sarah J Hallberg
A1 Nasir H Bhanpuri
A1 Amy L McKenzie
A1 Wayne W Campbell
A1 James P McCarter
A1 Stephen D Phinney
A1 Jeff S Volek
A1 Naga Chalasani
YR 2019
UL http://bmjopen.bmj.com/content/9/2/e023597.abstract
AB Objective One year of comprehensive continuous care intervention (CCI) through nutritional ketosis improves glycosylated haemoglobin(HbA1c), body weight and liver enzymes among patients with type 2 diabetes (T2D). Here, we report the effect of the CCI on surrogate scores of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis.Methods This was a non-randomised longitudinal study, including adults with T2D who were self-enrolled to the CCI (n=262) or to receive usual care (UC, n=87) during 1 year. An NAFLD liver fat score (N-LFS) >−0.640 defined the presence of fatty liver. An NAFLD fibrosis score (NFS) of >0.675 identified subjects with advanced fibrosis. Changes in N-LFS and NFS at 1 year were the main endpoints.Results At baseline, NAFLD was present in 95% of patients in the CCI and 90% of patients in the UC. At 1 year, weight loss of ≥5% was achieved in 79% of patients in the CCI versus 19% of patients in UC (p<0.001). N-LFS mean score was reduced in the CCI group (−1.95±0.22, p<0.001), whereas it was not changed in the UC (0.47±0.41, p=0.26) (CCI vs UC, p<0.001). NFS was reduced in the CCI group (−0.65±0.06, p<0.001) compared with UC (0.26±0.11, p=0.02) (p<0.001 between two groups). In the CCI group, the percentage of individuals with a low probability of advanced fibrosis increased from 18% at baseline to 33% at 1 year (p<0.001).Conclusions One year of a digitally supported CCI significantly improved surrogates of NAFLD and advanced fibrosis in patients with T2D.Trial registration number NCT02519309; Results.