Digitally-Supported Continuous Care Intervention Including Individualized Nutritional Ketosis Significantly Improves Surrogate Markers of Non-Alcoholic Fatty Liver Disease (NAFLD) and Liver Fibrosis in Patients with Type 2 Diabetes: An Open Label, Non-Randomized, Controlled Study

Vilar-Gomez, E.; Athinarayanan, S. J.; Hallberg, S. J.; Bhanpuri, N. H.; McKenzie, A. L.; Campbell, W. W.; McCarter, J. P.; Phinney, S. D.; Volek, J. S.; Chalasani, N.

doi:10.1101/293548

bioRxiv · 10.1101/293548

Digitally-Supported Continuous Care Intervention Including Individualized Nutritional Ketosis Significantly Improves Surrogate Markers of Non-Alcoholic Fatty Liver Disease (NAFLD) and Liver Fibrosis in Patients with Type 2 Diabetes: An Open Label, Non-Randomized, Controlled Study

Vilar-Gomez, E.·Athinarayanan, S. J.·Hallberg, S. J.·Bhanpuri, N. H.·McKenzie, A. L.·Campbell, W. W.·McCarter, J. P.·Phinney, S. D.·Volek, J. S.·Chalasani, N.

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Abstract

ObjectiveOne-year of comprehensive continuous care intervention (CCI) through nutritional ketosis improves HbA1c, body weight and liver enzymes among type 2 diabetes (T2D) patients. Here, we report the effect of the CCI on surrogate scores of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis. MethodsThis was a non-randomized longitudinal study, including adults with T2D who were self-enrolled to the CCI (n=262) or to receive usual care (UC, n=87) during one year. A NAFLD liver fat score [N-LFS] > -0.640 defined the presence of fatty liver. A NAFLD fibrosis score [NFS] of > 0.675 identified subjects with advanced fibrosis. Changes in N-LFS and NFS at one year were the main endpoints. ResultsAt baseline, NAFLD was present in 95% of patients in the CCI and 90% of patients in the UC. At one year, weight loss of > 5% was achieved in 79% of patients in the CCI vs. 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). ConclusionsOne year of a digitally-supported CCI significantly improved surrogates of NAFLD and advanced fibrosis in patients with type 2 diabetes. DATA SHARINGData sets and statistical code used for the current study are available from the corresponding author on reasonable request. Article Summary Strengths and limitations of this studyO_LIThis study highlights the beneficial effect of the CCI on NAFLD in high risk patients with T2D C_LIO_LIThis study also identifies positive associations between glycemic improvements and improvements in ALT levels C_LIO_LIThe assessment of resolution of steatosis and fibrosis is limited by the sensitivity and specificity of the non-invasive markers used in the study C_LIO_LIThe patients were restricted in their carbohydrate intake and monitored for their nutritional ketosis state, but dietary energy, macronutrient and micronutrient intakes were not assessed. C_LI

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Vilar-Gomez, E., Athinarayanan, S. J., Hallberg, S. J., Bhanpuri, N. H., McKenzie, A. L., Campbell, W. W., McCarter, J. P., Phinney, S. D., Volek, J. S., Chalasani, N.. 2018-04-05. Digitally-Supported Continuous Care Intervention Including Individualized Nutritional Ketosis Significantly Improves Surrogate Markers of Non-Alcoholic Fatty Liver Disease (NAFLD) and Liver Fibrosis in Patients with Type 2 Diabetes: An Open Label, Non-Randomized, Controlled Study. https://doi.org/10.1101/293548

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