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

NCT01827280 | Completed Phase 4 DMC

• 2 other identifiers: Galvus_2013BioVasc_2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

endothelial function; microvascular function; incretins; diabetes mellitus; postprandial lipemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline in endothelial function at 30 days

  before and after 30 days (intervention)

Other Outcomes (1)

• Change from Baseline in incretins and inflammation markers at 30 days

  basal and after 30 days (intervention)

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin 850mg/pill will be administered at lunch time and dinner time for 30 days

Drug: Vildagliptin

Vildagliptina

EXPERIMENTAL

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

Drug: Vildagliptin

Interventions

Vildagliptin DRUG

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

Also known as: Vildagliptin (galvus)

Metformin; Vildagliptina

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients should have BMI \> 30kg/m²
• Present untreated diabetes mellitus type 2
• Age between 19 and 50 years
• Waist Circumference \> 80 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Laboratory for Clinical and Experimental Research on Vascular Biology: collaborator

Study Sites (1)

Laboratory for Clinical and Experimental Research on Vascular Biology

Rio de Janeiro, 20550-900, Brazil

Location

Related Publications (1)

• Schiapaccassa A, Maranhao PA, de Souza MDGC, Panazzolo DG, Nogueira Neto JF, Bouskela E, Kraemer-Aguiar LG. 30-days effects of vildagliptin on vascular function, plasma viscosity, inflammation, oxidative stress, and intestinal peptides on drug-naive women with diabetes and obesity: a randomized head-to-head metformin-controlled study. Diabetol Metab Syndr. 2019 Aug 23;11:70. doi: 10.1186/s13098-019-0466-2. eCollection 2019.

  PMID: 31462933 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 9, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

BR (1)