Abstract
Aim: High prevalence of metabolic disorders causes higher risk of cardiovascular diseases after kidney transplantation (KT), which remains the main burden impairing short-term and long-term survival. This open-label, prospective, randomized, 3-arm, controlled trial will evaluate the safety, tolerability and efficacy of metformin and empagliflozin in ameliorating metabolic profiles after KT.Methods: After a screening assessment, eligible patients with an estimated glomerular filtration rate (eGFR) >45 mL/min/1.73m2 are randomly assigned to standard triple immunosuppression alone, standard immunosuppression plus metformin (500 mg twice daily), standard immunosuppression plus empagliflozin (25 mg once daily) from discharge. The primary endpoint is the differences in the visceral-to-subcutaneous fat area ratio over 12 months, evaluated by magnetic resonance imaging (MRI). Secondary outcomes include kidney graft function, glycometabolism, lipid metabolism, and inflammatory parameters. The trial will enroll 105 kidney transplant recipients, providing 90% power to detect the difference at 5% significance.
Highlights
Advances in patient selection, organ procurement and preservation, surgical technique, immunosuppression, and infection prevention have conferred significant improvement in rejection, infection, and subsequently decreased cause-specific graft failure rates after kidney transplantation (KT) [1]
Previous studies demonstrated that adenosine 5′-monophosphate (AMP)-activated protein kinase (AMPK) is a central regulator of multiple metabolic pathways and a key player in regulating cellular energy metabolism [7, 8]
Compared with the general population, high prevalence of metabolic disorders increases the risk of post-transplant cardiovascular diseases (CVD), which makes CVD a main post-transplant burden
Summary
Organ procurement and preservation, surgical technique, immunosuppression, and infection prevention have conferred significant improvement in rejection, infection, and subsequently decreased cause-specific graft failure rates after kidney transplantation (KT) [1]. A recent small clinical trial observed that metformin administration can safely ameliorate metabolic profiles in glucocorticoid-treated patients with inflammatory disease but without pre-existing diabetes [12] Another antidiabetic drug sodium-glucosecotransporter-2 (SGLT-2) inhibitors can improve metabolic parameters and cardiovascular risk in patients with or without diabetes in pre-clinical and clinical studies [13, 14, 14, 15]. Another small clinical trial even reported that compared to metformin, significant improvement in anthropometric parameters and body composition, in overweight and obese women with polycystic ovary syndrome after treatment with empagliflozin [16]. Metformin and SGLT2 inhibitors may be used as potential adjuvant therapies to improve metabolic disorders after KT
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