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
  Purpose

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.


Condition Intervention Phase
1- Microvascular Function
2-oxidative Stress
3-inflammation
Drug: Vildagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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).


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
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.
Other Name: Vildagliptin (galvus)
Experimental: Vildagliptina
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.
Other Name: Vildagliptin (galvus)

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827280

Contacts
Contact: Luiz Guilherme Kraemer de Aguiar, DO 55 21 23340703 gkraemer@ig.com.br

Locations
Brazil
Laboratory for Clinical and Experimental Research on Vascular Biology Not yet recruiting
Rio de Janeiro, Brazil, 20550-900
Contact: Priscila Maranhão, MSc    21 55 23340703    priscilamaranhao@gmail.com   
Principal Investigator: Luiz Guilherme Kraemer de Aguiar, phD         
Sub-Investigator: Eliete Bouskela, phD         
Sub-Investigator: Amélio Godoy-Matos, phD         
Sponsors and Collaborators
Rio de Janeiro State University
Laboratory for Clinical and Experimental Research on Vascular Biology
  More Information

No publications provided

Responsible Party: Luiz Guilherme Kraemer de Aguiar, Professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01827280     History of Changes
Other Study ID Numbers: Galvus_2013, BioVasc_2013
Study First Received: April 2, 2013
Last Updated: April 4, 2013
Health Authority: Brasil: Agência Nacional de vigilância Sanitária - national sanitary surveillance agency

Keywords provided by Rio de Janeiro State University:
endothelial function
microvascular function
incretins
diabetes mellitus
postprandial lipemia

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014