1- Microvascular Function Clinical Trial
Official title:
Acute and Short-term Chronic Effects of Galvus (Vildagliptin) on Endothelial Function and Oxidative Stress on Recently Diagnosed Type 2 Diabetic Obese Women: the Role of Intestinal Peptides During Lipid Overload
| Verified date | May 2017 |
| Source | Rio de Janeiro State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - All patients should have BMI > 30kg/m² - Present untreated diabetes mellitus type 2 - Age between 19 and 50 years - Waist Circumference > 80 cm Exclusion Criteria: - Renal, coronary vascular or peripheral, hematologic or hepatic disease - Presence of severe hypertriglyceridemia (> 400mg/dl) - Smokers - Significant body mass loss (> 5%) within the six months prior to the study |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Laboratory for Clinical and Experimental Research on Vascular Biology | Rio de Janeiro |
| Lead Sponsor | Collaborator |
|---|---|
| Rio de Janeiro State University | Laboratory for Clinical and Experimental Research on Vascular Biology |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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). | basal and after 30 days (intervention) | |
| Primary | 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. | Before and after 30 days | |
| Secondary | 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. | before and after 30 days (intervention) |