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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

ByCrossFitMay 24, 2019

Note: This trial presents an additional summary of data previously discussed on on May 14, 2019, and May 22, 2019.

This 2018 trial, funded by Virta Health, tested the impact of a high-compliance ketogenic diet on metabolic outcomes in Type 2 diabetics.

Nonalcoholic fatty liver disease (NAFLD) is an increasingly prevalent cause of liver damage and is found in 70% of obese, diabetic patients. No drugs have been shown to reverse NAFLD, and the current recommendation for patients with NAFLD (weight loss) is inconsistently effective. Low-carbohydrate diets and carbohydrate restriction have been shown to drive significant and rapid reductions in liver fat and liver enzymes. This trial was designed to test the impact of a ketogenic diet on various markers of liver health in highly compliant subjects over one year.

In this trial, 262 Type 2 diabetics were counseled to follow a diet that would achieve and sustain nutritional ketosis (i.e., blood BHB of 0.5 – 3.0 mmol/L). Each subject was given personalized, dynamic dietary guidance by a health coach who continuously communicated with each subject and tracked biomarkers via an app. As such, the specific diet varied by subject but generally involved 1.5 g/kg of protein intake and <30 g of carbohydrate intake per day, alongside non-starchy vegetables, multivitamins, and adequate fluids. Of the original 262 subjects, 218 completed one year of treatment.

At baseline, 95% of patients had NAFLD. Observed changes included (all figures refer to mean reductions; all listed changes were statistically significant):

  • N-LFS, a validated surrogate marker of fatty liver disease, decreased from 3.26 to 1.30; the share of patients with suspected steatosis decreased from 95% to 75%.
  • The share of patients without fibrosis increased from 18% to 33%.
  • Among patients with abnormal ALT (a marker of poor liver health) at baseline, 61% had normalized ALT at one year.
  • 54% of patients achieved weight loss ≥ 10%, and those patients who achieved this level of weight loss showed the greatest improvements in N-LFS.
  • 70% of patients achieved a reduction in HbA1c ≥ 0.5%; 65% of those with abnormal ALT at baseline who showed such an improvement in HbA1c also showed normalization of ALT, which suggests there is an association between these outcomes.
Figure 1

Figure 1

Collectively, these results demonstrated that compliance with a ketogenic diet for one year led to significant reductions in liver fat content and liver fibrosis. While a strict interpretation of these results does not allow extrapolation to other interventions, it would be reasonable to expect any diabetic patients following a ketogenic diet for one year to exhibit similar outcomes. Most importantly, 61% of patients with abnormal liver enzymes at baseline showed normalization (and an even higher percentage of patients concurrently showed significant weight loss and/or HbA1c reduction), which suggests compliance with a ketogenic diet can drive significant improvements in liver health over time.

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