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

NCT03911479 | Completed

• 1 other identifier: HRV_endo
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Rate variability and endothelial function

  assessed by peripheral arterial tonometry

  3 months

Study Arms (2)

Bariatric Surgery Group

EXPERIMENTAL

Procedure: Bariatric Surgery

Clinical Threatment

OTHER

Convencional treatment in a public tertiary outpatients care unit

Procedure: Bariatric Surgery

Interventions

Bariatric Surgery PROCEDURE

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

Bariatric Surgery Group; Clinical Threatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Eliete Bouskela: collaborator

Related Publications (1)

• Gomide Braga T, das Gracas Coelho de Souza M, Maranhao PA, Menezes M, Dellatorre-Teixeira L, Bouskela E, Le Roux CW, Kraemer-Aguiar LG. Evaluation of Heart Rate Variability and Endothelial Function 3 Months After Bariatric Surgery. Obes Surg. 2020 Jun;30(6):2450-2453. doi: 10.1007/s11695-020-04397-4.

  PMID: 31916132 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: October 1, 2015
• Primary Completion: February 25, 2016
• Study Completion: February 22, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share