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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.

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 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.

KEYWORDS:

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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