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. TRIAL REGISTRATION:Clinical Trials NCT02145611, registered on 11 Jun 2013.
journal_name
Diabetol Metab Syndrjournal_title
Diabetology & metabolic syndromeauthors
Cosenso-Martin LN,Giollo-Júnior LT,Martineli DD,Cesarino CB,Nakazone MA,Cipullo JP,Vilela-Martin JFdoi
10.1186/s13098-015-0062-zsubject
Has Abstractpub_date
2015-08-26 00:00:00pages
70issn
1758-5996pii
62journal_volume
7pub_type
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