Evolution of characteristics of MASLD with and without diabetes: a meta-analysis of placebo arms

Abstract

Abstract Background We explored the changes in metabolic dysfunction-associated steatotic liver disease (MASLD) severity over time by analyzing data from the placebo arms of randomized controlled trials (RCTs), focusing on the presence of diabetes. Methods RCTs on MASLD that included a placebo arm were identified using a systematic search of the literature. Primary outcomes were changes in hepatic steatosis and fibrosis. Results The meta-analysis included 8 RCTs involving 386 patients without diabetes and 24 RCTs involving 637 patients with diabetes. The pooled estimate of mean change in steatosis grade was − 0.1 in patients without diabetes, and − 0.37 in patients with diabetes (P = 0.066). The mean change in fibrosis stage was 0.05 in patients without diabetes, and − 0.03 in patients with diabetes (P = 0.359). The mean change in nonalcoholic fatty liver disease activity score was − 0.55 in patients without diabetes, and − 1.50 in patients with diabetes (P = 0.100). The mean change in ALT and AST were significantly larger in patients without diabetes compared to those with diabetes (P < 0.05). Conclusion Placebo treatment had a greater effect in improving liver steatosis in patients with diabetes compared to those without. These findings highlight the importance of tailored treatment strategies in MASLD, particularly considering diabetes status.

Keywords

• Metabolic dysfunction-associated steatotic liver disease
• Natural course
• Randomized controlled trial
• Steatosis
• Lifestyle modification