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BMJ Open. 2019 Feb 25;9(2):e023597. doi: 10.1136/bmjopen-2018-023597.

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.

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Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Virta Health, San Francisco, California, USA.
Indiana University Health Arnett, Lafayette, Indiana, USA.
Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA.
Department of Genetics, Washington University School of Medicine, St. Louis, Missouri, USA.
Department of Human Sciences, Ohio State University, Columbus, Ohio, USA.



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.


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.


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).


One year of a digitally supported CCI significantly improved surrogates of NAFLD and advanced fibrosis in patients with T2D.


NCT02519309; Results.


ketogenic diet; liver fibrosis; non-alcoholic fatty liver disease; type 2 diabetes; very low carb diet; weight loss

Conflict of interest statement

Competing interests: SJA, SJH, NHB, ALM, RNA, JPM and SDP are employees of Virta Health Corp and have been offered stock options. SDP and JSV are founders of Virta Health Corp. EV-G, WWC and NC have nothing relevant to declare.

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