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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
  1. Eduardo Vilar-Gomez1,
  2. Shaminie J Athinarayanan2,
  3. Rebecca N Adams2,
  4. Sarah J Hallberg2,3,
  5. Nasir H Bhanpuri2,
  6. Amy L McKenzie2,
  7. Wayne W Campbell4,
  8. James P McCarter2,5,
  9. Stephen D Phinney2,
  10. Jeff S Volek2,6,
  11. Naga Chalasani1
  1. 1 Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA
  2. 2 Virta Health, San Francisco, California, USA
  3. 3 Indiana University Health Arnett, Lafayette, Indiana, USA
  4. 4 Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA
  5. 5 Department of Genetics, Washington University School of Medicine, St. Louis, Missouri, USA
  6. 6 Department of Human Sciences, Ohio State University, Columbus, Ohio, USA
  1. Correspondence to Professor Naga Chalasani; nchalasa{at}iu.edu

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.

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

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors EV-G, SJA, RNA, JPM and NC wrote the manuscript. ALM, NHB, SJH and SJA participated in data acquisition. EV-G and SJA analysed the data. NC, SJH, NHB, ALM, WWC, JPM, SDP and JSV supervised this particular analysis and edited the manuscript. All authors approved the final version of the manuscript.

  • Funding Virta Health funded this study.

  • 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.

  • Patient consent Obtained.

  • Ethics approval Franciscan Health Lafayette Institutional Review Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data sets and statistical code used for the current study are available from the corresponding author on reasonable request.

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