title: Twelve-week randomized study to compare the effect of vildagliptin vs. glibenclamide both added-on to metformin on endothelium function in patients with type 2 diabetes and hypertension.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  It is expected that this DPP-4 inhibitor will improve endothelial function in patients with T2 DM.
  
  
  BACKGROUND
  Clinical Trials NCT02145611, registered on 11 Jun 2013.
authors: 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.
authors: Luciana Neves
authors: LN
authors: Cosenso-Martin
authors: 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.
authors: Luiz Tadeu
authors: LT
authors: Giollo-Júnior
authors: 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.
authors: Débora Dada
authors: DD
authors: Martineli
authors: 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.
authors: Cláudia Bernardi
authors: CB
authors: Cesarino
authors: 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.
authors: Marcelo Arruda
authors: MA
authors: Nakazone
authors: 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.
authors: José Paulo
authors: JP
authors: Cipullo
authors: 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.
authors: José Fernando
authors: JF
authors: Vilela-Martin
keywords: Arterial stiffness; DPP-4 inhibitor; Endothelial dysfunction; Hypertension; Type 2 diabetes mellitus