Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-02-22

Brief Summary

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Was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

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Detailed Description

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To assess the pathophysiological mechanisms that leads the benefits in cardiovascular risk after bariatric surgery, through the autonomic nervous system and endothelial function, was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment.

The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery.

Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Short-term, non-blinded, non-randomized longitudinal study comparing obese patients undergoing bariatric surgery with those on clinical treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bariatric Surgery Group

Group Type EXPERIMENTAL

Bariatric Surgery

Intervention Type PROCEDURE

Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)

Clinical Threatment

Convencional treatment in a public tertiary outpatients care unit

Group Type OTHER

Bariatric Surgery

Intervention Type PROCEDURE

Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)

Interventions

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Bariatric Surgery

Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients with obesity grade 3 \[Body Mass Index (BMI) ≥ 40kg/m2\] or grade 2 (BMI 35-39.9kg/m2) with comorbidities

Exclusion Criteria

Current use of incretin mimetics or inhibitors of dipeptidyl peptidase-4 (DPP4); and history of a previous cardiovascular event (acute myocardial infarction, stroke or peripheral obstructive arterial disease)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No