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

Study Overview
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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.

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.

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

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Bariatric Surgery


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Short-term, non-blinded, non-randomized longitudinal study comparing obese patients undergoing bariatric surgery with those on clinical treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bariatric Surgery Group<br> | Procedure: Bariatric Surgery<br>* Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)<br>|
| Other: Clinical Threatment<br>Convencional treatment in a public tertiary outpatients care unit | Procedure: Bariatric Surgery<br>* Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate variability and endothelial function | assessed by peripheral arterial tonometry | 3 months |