Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Sci Rep. 2023 Mar 1;13(1):3479. doi: 10.1038/s41598-023-30643-7.
The aim of the present study was to investigate the effect of linagliptin on microalbuminuria in patients with diabetic nephropathy (DN). The present double-blind randomized placebo-controlled clinical trial was performed on 92 patients with DN who were divided into two groups. The intervention and control groups received linagliptin 5 mg and placebo for 24 weeks, respectively. Blood pressure, lipid profile, liver enzymes, fasting plasma glucose (FPG), and urine albumin-creatinine ratio (UACR) were assessed and recorded before, 12 weeks, and 24 weeks after the beginning of the intervention. The mean value of UACR decrease was significant over time in both groups, with higher decrease in linagliptin group, however, the differences between two groups were not, statistically significant (P > 0.05). However, the percentage of improvement in microalbuminuria (UACR < 30 mg/g) in the linagliptin group was significantly higher than that of the control group during 24 weeks of intervention (68.3% vs. 25%; P-value < 0.001). There was no statistically significant difference in the mean value of the UACR and other parameters between linagliptin treated and placebo treated patients with diabetic nephropathy. Further studies, with longer periods of follow-up are suggested to examine these patients' renal outcomes.
本研究旨在探讨利拉利汀对糖尿病肾病(DN)患者微量白蛋白尿的影响。本双盲随机安慰剂对照临床试验纳入了 92 例 DN 患者,将其分为两组。干预组和对照组分别接受利拉利汀 5mg 和安慰剂治疗 24 周。在干预开始前、12 周和 24 周时评估并记录血压、血脂谱、肝酶、空腹血糖(FPG)和尿白蛋白肌酐比(UACR)。两组的 UACR 均值随时间均呈显著下降趋势,利拉利汀组下降更为明显,但两组间差异无统计学意义(P>0.05)。然而,在 24 周的干预期间,利拉利汀组中微量白蛋白尿(UACR<30mg/g)改善的百分比显著高于对照组(68.3% vs. 25%;P 值<0.001)。在接受利拉利汀治疗和安慰剂治疗的糖尿病肾病患者中,UACR 和其他参数的均值之间无统计学显著差异。建议进行进一步的研究,以观察这些患者的肾脏结局。