Acute and Short-term Chronic Effects of Galvus (Vildagliptin) in Diabetes Type 2 Obese Women
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Rio de Janeiro State University
Collaborator:
Laboratory for Clinical and Experimental Research on Vascular Biology