ABSTRACTObjectiveOne-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 studyThis study highlights the beneficial effect of the CCI on NAFLD in high risk patients with T2DThis study also identifies positive associations between glycemic improvements and improvements in ALT levelsThe assessment of resolution of steatosis and fibrosis is limited by the sensitivity and specificity of the non-invasive markers used in the studyThe patients were restricted in their carbohydrate intake and monitored for their nutritional ketosis state, but dietary energy, macronutrient and micronutrient intakes were not assessed.
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-Randomized, Controlled Study
