Cosenso-Martin Luciana Neves, Giollo-Júnior Luiz Tadeu, Martineli Débora Dada, Cesarino Cláudia Bernardi, Nakazone Marcelo Arruda, Cipullo José Paulo, Vilela-Martin José Fernando
Hospital de Base/Centro Integrado de Pesquisa da Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME), São José do Rio Preto, Brazil ; Internal Medicine Department and Hypertension Clinic, State Medical School in São José do Rio Preto (FAMERP), Ave Brig. Faria Lima 5416, São José do Rio Preto, SP 15090-000 Brazil.
Diabetol Metab Syndr. 2015 Aug 26;7:70. doi: 10.1186/s13098-015-0062-z. eCollection 2015.
Vildagliptin, a DPP-4 inhibitor widely used for the treatment of type 2 diabetes mellitus (T2DM), shows beneficial effects on endothelial function. This study aims to evaluate the effect of vildagliptin on endothelial function and arterial stiffness in patients with T2DM and hypertension.
Fifty over 35-year-old patients with T2DM and hypertension, without cardiovascular disease, will be randomly allocated to two groups: group 1 will receive vildagliptin added-on to metformin and group 2, glibenclamide added-on to metformin. Biochemical tests (glycemia, glycated hemoglobin, total cholesterol, high-density lipoprotein cholesterol, triglycerides, creatinine, alanine aminotransferase, ultrasensitive C-reactive protein, and microalbuminuria), 24-h non-invasive ambulatory blood pressure monitoring, and assessment of endothelial function and arterial stiffness will be performed in both groups before and after 12 weeks of treatment. The endothelial function will be assessed by peripheral arterial tonometry, which measures the reactive hyperemia index (vasodilation), and arterial stiffness will be evaluated by applanation tonometry. All analysis will be performed using SPSS Statistical Software. For all analysis, a 2-sided P < 0.05 will be considered statistically significant.
The study started in December 2013 and patient recruitment is programed until October 2015. The expected results are that vildagliptin will improve the endothelial function in patients with T2DM and hypertension compared to glibenclamide treatment, independently of glycemic control.
It is expected that this DPP-4 inhibitor will improve endothelial function in patients with T2 DM.
Clinical Trials NCT02145611, registered on 11 Jun 2013.
维格列汀是一种广泛用于治疗2型糖尿病（T2DM）的二肽基肽酶-4（DPP-4）抑制剂，对内皮功能具有有益作用。本研究旨在评估维格列汀对T2DM合并高血压患者内皮功能和动脉僵硬度的影响。
50例年龄超过35岁、无心血管疾病的T2DM合并高血压患者将被随机分为两组：第1组在二甲双胍基础上加用维格列汀，第2组在二甲双胍基础上加用格列本脲。两组在治疗12周前后均将进行生化检测（血糖、糖化血红蛋白、总胆固醇、高密度脂蛋白胆固醇、甘油三酯、肌酐、丙氨酸转氨酶、超敏C反应蛋白和微量白蛋白尿）、24小时无创动态血压监测以及内皮功能和动脉僵硬度评估。内皮功能将通过测量反应性充血指数（血管舒张）的外周动脉张力测定法进行评估，动脉僵硬度将通过压平式张力测定法进行评估。所有分析将使用SPSS统计软件进行。对于所有分析，双侧P<0.05将被认为具有统计学意义。
该研究于2013年12月开始，计划招募患者至2015年10月。预期结果是，与格列本脲治疗相比，维格列汀将改善T2DM合并高血压患者的内皮功能，且独立于血糖控制情况。
预计这种DPP-4抑制剂将改善T2DM患者的内皮功能。
临床试验NCT02145611，于2013年6月11日注册。
