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Acute and Short-term Chronic Effects of Galvus (Vildagliptin) in Diabetes Type 2 Obese Women

NCT01827280 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-31

No results posted yet for this study

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.

Conditions

  • 1- Microvascular Function
  • 2-oxidative Stress
  • 3-inflammation

Interventions

DRUG

Vildagliptin

Vildagliptin 50mg/pill will be administered at 10 AM and at 6 PM also for 30 days.

Sponsors & Collaborators

  • Laboratory for Clinical and Experimental Research on Vascular Biology

    collaborator UNKNOWN

  • Rio de Janeiro State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-08-31
Completion
2016-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01827280 on ClinicalTrials.gov