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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911479
• Other study ID #: HRV_endo
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: February 22, 2018

Study information

• Verified date: April 2019
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 22, 2018
• Est. primary completion date: February 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Eliete Bouskela

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate variability and endothelial function	assessed by peripheral arterial tonometry	3 months