We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827280
First Posted: April 9, 2013
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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: Single (Participant)
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 Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University:

Primary Outcome Measures:
  • Change from Baseline in microcirculation function at 30 days [ Time Frame: Before and after 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.


Secondary Outcome Measures:
  • Change from Baseline in endothelial function at 30 days [ Time Frame: before and after 30 days (intervention) ]
    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) ]
    Through kits read by Multiplex® appliance, inflammatory markers will be evaluated, all simultaneously, with small sample quantity (from 10 to 50µL).


Enrollment: 40
Actual Study Start Date: April 2013
Study Completion Date: November 2016
Primary Completion Date: August 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827280


Locations
Brazil
Laboratory for Clinical and Experimental Research on Vascular Biology
Rio de Janeiro, Brazil, 20550-900
Sponsors and Collaborators
Rio de Janeiro State University
Laboratory for Clinical and Experimental Research on Vascular Biology
  More Information

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 ( Registry Identifier: BioVasc_2013 )
First Submitted: April 2, 2013
First Posted: April 9, 2013
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Luiz Guilherme Kraemer de Aguiar, 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
Hypoglycemic Agents
Physiological Effects of Drugs