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. Issue 2 (25th February 2019)

• Record Type: Journal Article
• Authors: Vilar-Gomez, Eduardo; Athinarayanan, Shaminie J; Adams, Rebecca N; Hallberg, Sarah J; Bhanpuri, Nasir H; McKenzie, Amy L; Campbell, Wayne W; McCarter, James P; Phinney, Stephen D; Volek, Jeff S; Chalasani, Naga
• Is Part Of: BMJ open. Volume 9:Issue 2(2019)
• Publication Date: 2019-02-25
• Subjects: type 2 diabetes -- very low carb diet -- ketogenic diet -- non-alcoholic fatty liver disease -- liver fibrosis -- weight loss; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-023597
• Languages: English
• ISSNs: 2044-6055

Abstract

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 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.