Author information
1 Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
2 Virta Health, San Francisco, California, USA.
3 Indiana University Health Arnett, Lafayette, Indiana, USA.
4 Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA.
5 Department of Genetics, Washington University School of Medicine, St. Louis, Missouri, USA.
6 Department of Human Sciences, Ohio State University, Columbus, Ohio, USA.
Abstract
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 liverfibrosis.
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.