PT  - JOURNAL ARTICLE
AU  - Eduardo Vilar-Gomez
AU  - Shaminie J. Athinarayanan
AU  - Sarah J. Hallberg
AU  - Nasir H. Bhanpuri
AU  - Amy L. McKenzie
AU  - Wayne W. Campbell
AU  - James P. McCarter
AU  - Stephen D. Phinney
AU  - Jeff S. Volek
AU  - Naga Chalasani
TI  - 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
AID  - 10.1101/293548
DP  - 2018 Jan 01
TA  - bioRxiv
PG  - 293548
4099  - http://biorxiv.org/content/early/2018/04/05/293548.short
4100  - http://biorxiv.org/content/early/2018/04/05/293548.full
AB  - Aims One-year of comprehensive continuous care intervention (CCI) through nutritional ketosis significantly improves HbA1c, body weight and liver enzymes among type 2 diabetes (T2D) patients. Here, we report the effect of CCI on surrogate scores of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis.Materials and methods This was a non-randomized longitudinal study, including adults with T2D who were self-enrolled to CCI (n=262) or to receive usual care (UC, n=87) during 1 year. The NAFLD liver fat score [N-LFS] > -0.640 defined the presence of fatty liver. The 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.Results At 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 with CCI vs. 16% of patients with UC (P<.01). N-LFS mean score levels were significantly reduced in the CCI (-1.85 ± 0.33) compared with UC (+0.19 ± 0.64) (P<.01). NFS was significantly reduced in the CCI group (-.370 ± 0.10, P<0.01) whereas it increased in the UC group (.256 ± 0.20, P=0.21) (P<.01 between two groups). In the CCI group, the presence of advanced fibrosis was reduced from 27% at baseline to 17% at 1 year (P<.01).Conclusions One-year of a digitally supported CCI significantly improved surrogates of NAFLD and advanced fibrosis in type 2 diabetes patients.Authors thank Drs. Marwan Ghabril and Raj Vuppalanchi for their helpful discussions with various analyses.Author contributionsE.V.G, S.J.A, J.P.M and N.P.C wrote the manuscript. A.L.M, N.H.B, S.J.H and S.J.A participated in data acquisition. E.V.G and S.J.A analyzed the data. N.P.C, S.J.H, N.H.B, A.L.M, W.W.C, J.P.M, S.D.P and J.S.V supervised this particular analysis and edited the manuscript. All authors approved the final version of the manuscript.AbbreviationsCCIcontinuous care interventionUCusual careNAFLDnon-alcoholic fatty liver disease;N-LFSnon-alcoholic liver fatty scoreNFSnon-alcoholic fatty liver disease fibrosis scoreCLDchronic liver diseaseHCChepatocellular carcinomaT2Dtype 2 diabetesNASHnon-alcoholic steatohepatitisBMIbody mass indexLCHFlow-carb high-fatALTalanine aminotransferaseASTaspartate aminotransferaseIHLCintrahepatic lipid contentADAAmerican Diabetes AssociationBHBbeta-hydroxybutyrateCLIAclinical laboratory improvement amendmentsITTintention-to-treatMIMmultiple imputation methodsWLweight lossEOTend-of-treatmentHDLhigh density lipoproteinRCTrandomized controlled trialLCDlow-carb dietKDketogenic dietHFDhigh-fat diet.