Comprehensive continuous care intervention with a ketogenic diet significantly improved surrogate markers of nonalcoholic fatty liver disease and advanced fibrosis in patients with type 2 diabetes after 1 year, according to data published in BMJ Open.
Eduardo Vilar-Gomez, MD, PhD, from the Indiana University School of Medicine, and colleagues wrote that low-carbohydrate, high-fat and ketogenic diets have demonstrated significant weight loss effects in adults with overweight and obesity. In the short-term, these diets have also correlated with improved insulin sensitivity and glycemic control.
“Lower consumption of carbohydrate ... and ketogenic diets improve appetite control, satiety and/or reduce daily food intake helping to limit dietary energy consumption while maintaining patient-perceived vigor,” they wrote.
The researchers enrolled 262 patients to receive digitally supported comprehensive continuous care intervention (CCI) with a ketogenic diet and 87 controls who received usual care for 1 year. Most participants had suspicion of NAFLD (95%), were obese with a mean BMI of 39.5 kg/m2 (90%) and were taking medication for diabetes (84%).
At 1 year, patients in the CCI group demonstrated a reduction in suspected steatosis (95% to 75%) and an increase in the proportion of those without fibrosis (18% to 33%; P < .001), whereas there were no such changes in the usual care group. Patients in the CCI group were also more likely to achieve 5% or more weight loss (79% vs. 19.5%) and 10% or more weight loss (54% vs. 6%) than the usual care group.
Patients in the CCI group who achieved 10% or more weight loss had significant reductions in noninvasive markers of steatosis (P < .001), NAFLD-related fibrosis (P < .001), HbA1c (P < .001) and triglycerides (P < .001).
Changes in HbA1c (P = .03), weight (P = .004) and fasting glucose (P = .004) in the full cohort correlated with changes in alanine aminotransferase levels. HbA1c reduction of 0.5% or more at 1-year increased the odds for ALT normalization by 2.4-fold (95% CI, 1.09-5.3) and correlated with higher rates of ALT normalization regardless of whether a patient achieved 5% weight loss (P < .001).
The researchers noted no hepatic decompensation or ALT flares during the trial in either the CCI or usual care group.
“The influence of carbohydrate restriction and nutritional ketosis on liver histology of patients with biopsy-proven [nonalcoholic steatohepatitis] remains largely unexplored in the context of a well-designed randomized controlled trial,” Vilar-Gomez and colleagues wrote. “Medical interventions incorporating ketogenic diets appear effective for improving NAFLD and therefore may be an effective approach for reversing the natural history of NAFLD progression, although further studies are needed to confirm potential beneficial effect in patients with biopsy-confirmed NASH.” – by Talitha Bennett
Disclosure: Virta Health funded this study. Vilar-Gomez reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.