A Phase 4 interventional study of Vildagliptin in 1- Microvascular Function, 2-oxidative Stress and 3-inflammation, sponsored by Rio de Janeiro State University. Completed at 1 site in Brazil. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-05-31.
Sponsored by Rio de Janeiro State University · Phase 4, Interventional, and Treatment
The prevalence of obesity and type 2 diabetes mellitus (T2DM) has increased progressively in the past decades, and consequently, a higher incidence of cardiovascular diseases is observed. As this process develops, the endothelial dysfunction is present at early stages of the atherosclerotic disease. Studies conducted at BioVasc/UERJ show the occurrence of endothelial and microvascular dysfunction in obese carriers, even in the absence of dysglycemia. New concepts indicate the endothelium as a possible therapeutic target, and drugs which act not only on diabetes mellitus pathophysiology but also acting as direct cardiovascular protectors bring new therapeutic possibilities. The dipeptidyl-peptidase-4 inhibitors (DPP4), such as vildagliptin, are drugs used on the T2DM treatment. Its incretin mimetic and insulinotropic effects are already well established and several other studies show its effectiveness in reducing glycated hemoglobin, even in monotherapy.
Currently, fat rich foods are being increasingly introduced in the western way of life and recent evidence suggests that the postprandial lipemia (LPP) is related to cardiovascular risk. A better glucose control using vildagliptin can reduce the oxidative stress, and consequently promote a better microvascular and endothelial reactivity. However, vildagliptin can have an additional cardiovascular protective action, not only because of its effect on glycemia and oxidative stress reduction, but maybe because of its direct effect on intestinal peptides with postprandial lipemia reduction. To test this hypothesis, we will proceed the following exams: venous occlusion pletysmography, nailfold videocapilaroscopy and laser-Doppler flowmetry aiming to evaluate vascular reactivity on muscle and at cutaneous site. Anoter group of patients with the same clinical charactherisitics will use metformin, in order to compare its effects with those obtained from the use of Vildaglitpin. Our purpose is to determine whether vildagliptin, evaluated in obese and diabetic women, has vascular protective effects, and whether the regulatory mechanisms of these actions correlate with oxidative stress, inflammatory markers and intestinal peptides in baseline state and after a lipid overload.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Rio de Janeiro State University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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Metformin 850mg/pill will be administered at lunch time and dinner time for 30 days
Drug: Vildagliptin
Vildagliptin 50mg/pill will be administered at 10 AM and at 6 PM also for 30 days.
Drug: Vildagliptin
Vildagliptin 50mg/pill will be administered at 10 AM and at 6 PM also for 30 days.
Also known as: Vildagliptin (galvus)
Change from Baseline in microcirculation function at 30 days
For this study, there will be used two methods, the traditional one, which consists in assessing the microcirculation parameters by dynamic nailfold videocapillaroscopy technique carried out in the nailfold pleat of the fourth finger on the left hand.
Time frame: Before and after 30 days
Change from Baseline in endothelial function at 30 days
LDF is a method for continuous non invasive determination of the microvascular perfusion, where the study of cutaneous vasomotion by spectral analysis of Laser Doppler signal allows the exploration of five frequency components: endothelial, myogenic, sympathetic, respiratory and cardiac, involved in answers to the stimuli. Therewith vasomotion during the whole study period will be assessed, to find differences in baseline, 30, 60, 120 and 180 min after the meal rich in lipids.
Time frame: before and after 30 days (intervention)
Change from Baseline in incretins and inflammation markers at 30 days
Through kits read by Multiplex® appliance, inflammatory markers will be evaluated, all simultaneously, with small sample quantity (from 10 to 50µL).
Time frame: basal and after 30 days (intervention)
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Rio de Janeiro State University