Yin Saifu, Ma Ming, Huang Zhongli, Fan Yu, Wang Xianding, Song Turun, Lin Tao
Department of Urology, West China Hospital, Sichuan University, Chengdu, China.
Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.
Front Med (Lausanne). 2021 Dec 23;8:800872. doi: 10.3389/fmed.2021.800872. eCollection 2021.
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. 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.
代谢紊乱的高患病率导致肾移植（KT）后心血管疾病风险增加，这仍然是影响短期和长期生存的主要负担。这项开放标签、前瞻性、随机、三臂对照试验将评估二甲双胍和恩格列净在改善KT后代谢状况方面的安全性、耐受性和疗效。经过筛查评估，估计肾小球滤过率（eGFR）>45 mL/min/1.73m²的合格患者从出院起被随机分配至单独接受标准三联免疫抑制治疗、标准免疫抑制治疗加二甲双胍（每日两次，每次500 mg）、标准免疫抑制治疗加恩格列净（每日一次，每次25 mg）。主要终点是通过磁共振成像（MRI）评估的12个月内内脏与皮下脂肪面积比的差异。次要结局包括肾移植功能、糖代谢、脂质代谢和炎症参数。该试验将招募105名肾移植受者，在5%显著性水平下提供90%的检验效能以检测差异。
