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), particularly in relation to the presence of diabetes. Methods: RCTs on MASLD that included a placebo arm were identified using a systematic search of the literature. The primary outcomes were the 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 by histology was -0.1 in patients without diabetes, and -0.37 in patients with diabetes (P=0.066). The mean change in fibrosis stage by histology 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 (-20.22 IU/L vs. -4.48 IU/L) and AST (-10.67 IU/L vs. -2.58 IU/L) were significantly larger in patients without diabetes compared to those with diabetes (P <0.05). Conclusion: In the placebo arm, patients with diabetes showed greater improvement in liver steatosis than those without diabetes.