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

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ClinicalTrials.gov Identifier: NCT03911479
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Eliete Bouskela
Information provided by (Responsible Party):
Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Bariatric Surgery Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : February 25, 2016
Actual Study Completion Date : February 22, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bariatric Surgery Group Procedure: Bariatric Surgery
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
 Procedure: Bariatric Surgery
Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)


Outcome Measures
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Primary Outcome Measures :
  1. Rate variability and endothelial function [ Time Frame: 3 months ]
    assessed by peripheral arterial tonometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luiz Guilherme Kraemer-Aguiar, MD, MD, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT03911479    
Other Study ID Numbers: HRV_endo
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No