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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Rio de Janeiro State University
Sponsor:
Collaborator:
Laboratory for Clinical and Experimental Research on Vascular Biology
Information provided by (Responsible Party):
Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01827280
First received: April 2, 2013
Last updated: April 4, 2013
Last verified: April 2013

April 2, 2013
April 4, 2013
April 2013
February 2014   (final data collection date for primary outcome measure)
Change from Baseline in microcirculation function at 30 days [ Time Frame: Before and after 30 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01827280 on ClinicalTrials.gov Archive Site
Change from Baseline in endothelial function at 30 days [ Time Frame: before and after 30 days (intervention) ] [ Designated as safety issue: No ]
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.
Same as current
Change from Baseline in incretins and inflammation markers at 30 days [ Time Frame: basal and after 30 days (intervention) ] [ Designated as safety issue: No ]
Through kits read by Multiplex® appliance, inflammatory markers will be evaluated, all simultaneously, with small sample quantity (from 10 to 50µL).
Same as current
 
Acute and Short-term Chronic Effects of Galvus (Vildagliptin) in Diabetes Type 2 Obese Women
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 1- Microvascular Function
  • 2-oxidative Stress
  • 3-inflammation
Drug: Vildagliptin
Vildagliptin 50mg/pill will be administered at 10 AM and at 6 PM also for 30 days.
Other Name: Vildagliptin (galvus)
  • Experimental: Metformin
    Metformin 850mg/pill will be administered at lunch time and dinner time for 30 days
    Intervention: Drug: Vildagliptin
  • Experimental: Vildagliptina
    Vildagliptin 50mg/pill will be administered at 10 AM and at 6 PM also for 30 days.
    Intervention: Drug: Vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Female
19 Years to 50 Years
No
Contact: Luiz Guilherme Kraemer de Aguiar, DO 55 21 23340703 gkraemer@ig.com.br
Brazil
 
NCT01827280
Galvus_2013, BioVasc_2013
Yes
Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University
Rio de Janeiro State University
Laboratory for Clinical and Experimental Research on Vascular Biology
Not Provided
Rio de Janeiro State University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP