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

Eduardo Vilar-Gomez, Shaminie J. Athinarayanan, Rebecca N. Adams, Sarah J. Hallberg, Nasir H. Bhanpuri, Amy L. McKenzie, Wayne W. Campbell, James P. McCarter, Stephen D. Phinney, Jeff S. Volek, Naga Chalasani

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Article number023597
JournalBMJ Open
Volume9
Issue number2
DOIs
StatePublished - Feb 1 2019

Fingerprint

Liver Cirrhosis
Type 2 Diabetes Mellitus
Biomarkers
Fibrosis
Liver
Fats
Non-alcoholic Fatty Liver Disease
Ketosis
Glycosylated Hemoglobin A
Fatty Liver
Longitudinal Studies
Weight Loss
Body Weight
Enzymes

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. / Vilar-Gomez, Eduardo; Athinarayanan, Shaminie J.; Adams, Rebecca N.; Hallberg, Sarah J.; Bhanpuri, Nasir H.; McKenzie, Amy L.; Campbell, Wayne W.; McCarter, James P.; Phinney, Stephen D.; Volek, Jeff S.; Chalasani, Naga.

In: BMJ Open, Vol. 9, No. 2, 023597, 01.02.2019.

Research output: Contribution to journalArticle

Vilar-Gomez, Eduardo ; Athinarayanan, Shaminie J. ; Adams, Rebecca N. ; Hallberg, Sarah J. ; Bhanpuri, Nasir H. ; McKenzie, Amy L. ; Campbell, Wayne W. ; McCarter, James P. ; Phinney, Stephen D. ; Volek, Jeff S. ; Chalasani, Naga. / 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. In: BMJ Open. 2019 ; Vol. 9, No. 2.
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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.",
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T1 - 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

T2 - An open-label, non-randomised controlled study

AU - Vilar-Gomez, Eduardo

AU - Athinarayanan, Shaminie J.

AU - Adams, Rebecca N.

AU - Hallberg, Sarah J.

AU - Bhanpuri, Nasir H.

AU - McKenzie, Amy L.

AU - Campbell, Wayne W.

AU - McCarter, James P.

AU - Phinney, Stephen D.

AU - Volek, Jeff S.

AU - Chalasani, Naga

PY - 2019/2/1

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N2 - 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.

AB - 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.

KW - ketogenic diet

KW - liver fibrosis

KW - non-alcoholic fatty liver disease

KW - type 2 diabetes

KW - very low carb diet

KW - weight loss

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