Sagara Masaaki, Suzuki Kunihiro, Aoki Chie, Tanaka Seiichi, Taguchi Isao, Inoue Teruo, Aso Yoshimasa
Department of Endocrinology and Metabolism, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi, 321-0293, Japan.
Department of Cardiology, Dokkyo Medical University, Koshigaya, Saitama, Japan.
Cardiovasc Diabetol. 2016 May 17;15:76. doi: 10.1186/s12933-016-0396-3.
The aim of the present study was to elucidate the effect of teneligliptin on oxidative stress and endothelial function in Japanese patients with type 2 diabetes and chronic kidney disease (CKD).
Forty-five patients with type 2 diabetes and CKD who received sitagliptin for at least 12 months were randomized to either continue sitagliptin (n = 23) or switch to teneligliptin (n = 22) for 24 weeks. The following parameters were evaluated at baseline and after 24 weeks of treatment with continued sitagliptin or teneligliptin: blood pressure, haemoglobin A1c (HbA1c), estimated glomerular filtration rate (eGFR), urinary albumin excretion, endothelial function by reactive hyperaemia index (RHI; EndoPAT(®) system), reactive oxygen metabolites (ROMs) measured by the d-ROMS test, 8-hydroxy-2'-deoxyguanosine, urinary liver-type fatty acid binding protein (L-FABP), and urinary 8-isoprostane.
The two groups did not significantly differ with regard to age, male-to-female ratio, duration of diabetes, body mass index, HbA1c, eGFR, or urinary albumin excretion levels at baseline. We found no significant differences in changes of HbA1c, eGFR, or urinary albumin excretion levels between the two groups after 24 weeks of treatment. However, treatment with teneligliptin, but not sitagliptin, significantly improved RHI values and was correlated with the percent changes in RHI and d-ROMs.
The present study demonstrated that teneligliptin, can improve endothelial function and reduce renal and vascular oxidative stress in patients with type 2 diabetes and CKD, independently of reducing albuminuria or improving glucose control. Trial registration UMIN000017180.
本研究旨在阐明替格列汀对日本2型糖尿病合并慢性肾脏病（CKD）患者氧化应激和内皮功能的影响。
45例接受西格列汀治疗至少12个月的2型糖尿病合并CKD患者被随机分为两组，一组继续使用西格列汀（n = 23），另一组换用替格列汀（n = 22），治疗24周。在基线以及继续使用西格列汀或换用替格列汀治疗24周后，评估以下参数：血压、糖化血红蛋白（HbA1c）、估计肾小球滤过率（eGFR）、尿白蛋白排泄量、通过反应性充血指数（RHI；EndoPAT®系统）评估的内皮功能、通过d-ROMS试验测量的活性氧代谢产物（ROMs）、8-羟基-2'-脱氧鸟苷、尿肝型脂肪酸结合蛋白（L-FABP）和尿8-异前列腺素。
两组在年龄、男女比例、糖尿病病程、体重指数、HbA1c、eGFR或基线时的尿白蛋白排泄水平方面无显著差异。治疗24周后，两组在HbA1c、eGFR或尿白蛋白排泄水平的变化方面无显著差异。然而，替格列汀治疗可显著改善RHI值，而西格列汀则无此作用，且RHI的改善与d-ROMs的变化百分比相关。
本研究表明，替格列汀可改善2型糖尿病合并CKD患者的内皮功能，降低肾脏和血管的氧化应激，且独立于降低蛋白尿或改善血糖控制。试验注册号UMIN000017180。
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