Adding empagliflozin to ongoing metformin improves metabolic profile, tg-g and fib-4 indexes and liver function tests in type 2 diabetic patients with NAFLDS, a clinical trial.

Abstract

Background: SGLT2 inhibitors offer strong glucose-lowering effects in patients with T2DM, but their impact on MAFLD when added to ongoing metformin therapy is not fully understood. This study aimed to evaluate the effects of empagliflozin (a SGLT2 inhibitor) on metabolic profile, liver fibrosis index, and liver function tests in metformin-treated T2DM patients with MAFLD.

Research design and methods: This 12-week, prospective, single-center clinical trial enrolled 80 T2DM patients with MAFLD who were already receiving metformin but required further intervention. They received empagliflozin (10 mg/day) in addition to metformin (2000 mg/day). Metabolic parameters including FBS, HbA1c, Chol, TG, LDL, HDL, vitamin D3, ALT, ALP, and AST were measured at baseline and after 12 weeks. Triglyceride-glucose (TG-G) index and fibrosis-4 (FIB-4) score were also calculated.

Results: Seventy-four patients completed the trial. Significant reductions were seen in FBS, HbA1c, Chol, LDL, TG, and TG-G index (p < 0.001). Liver markers ALT, AST, and FIB-4 also improved significantly (p < 0.001 and p < 0.02, respectively). Although HDL, ALP, and vitamin D3 increased, these changes were not statistically significant.

Conclusion: Adding empagliflozin to ongoing metformin significantly improved metabolic and liver-related markers in T2DM patients with MAFLD, supporting its therapeutic benefit in this population (Clinical Trial Registration: https://irct.behdasht.gov.ir/trial/73164).