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

NCT ID: NCT01827280

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Metformin

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

Group Type: EXPERIMENTAL

Vildagliptin

Intervention Type: DRUG

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

Vildagliptina

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

Group Type: EXPERIMENTAL

Vildagliptin

Intervention Type: DRUG

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

Interventions

Vildagliptin

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

Intervention Type: DRUG

Other Intervention Names

Vildagliptin (galvus)

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Laboratory for Clinical and Experimental Research on Vascular Biology

UNKNOWN

Sponsor Role: collaborator

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Luiz Guilherme Kraemer de Aguiar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laboratory for Clinical and Experimental Research on Vascular Biology

Rio de Janeiro, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31462933 (View on PubMed)

Other Identifiers

BioVasc_2013

Identifier Type: REGISTRY

Identifier Source: secondary_id

Galvus_2013

Identifier Type: -

Identifier Source: org_study_id