Abstract
Sodium-glucose co-transporter type-2 (SGLT2) inhibitors have been identified to have a crucial hepatoprotective role in patients with type 2 diabetes (T2DM) and metabolic-associated steatotic liver disease (MASLD). Thus, we aimed to assess the effect of SGLT2 inhibitors on hepatic steatosis in patients with T2DM and MASLD added to the standard of care (SOC) treatment. Our study was a single-arm clinical trial with trial no ISRCTN85961860. Thirty T2DM patients with MASLD were recruited from the outpatient endocrinology and diabetes clinic of the Internal Medicine Department at Kasr Al-Aini Hospital, Cairo University, Egypt. Our Patients received Empagliflozin 10 mg daily which was added to SOC treatment and followed up for 24 weeks. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) was done at baseline and after 24 weeks to assess the percentage change in hepatic fat mass. Also changes in Fib-4 and NAFLD fibrosis scores were calculated. Our study showed a statistically significant decrease in the mean MRI-PDFF measurement of hepatic steatosis after 24 weeks of adding empagliflozin to SOC treatment (13.297 ± 7.15) compared to the mean at baseline (15.288 ± 8.72), P = 0.006 with overall percentage decrease about 13.16% of liver steatosis. There were significant decreases in BMI, fasting blood glucose, and Alanine transaminase, (P < 0.001, 0.03, 0.01) respectively. There were no significant differences in Fib-4 or NAFLD fibrosis scores. Adding empagliflozin 10 mg to the standard treatment in patients with diabetes and MASLD could reduce hepatic fat mass significantly after 24 weeks of treatment. Thus, adding SGLT2 inhibitors to the clinical practice guidelines could be a therapeutic agent for patients with MASLD and T2DM.