Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects

Effects of Bariatric Surgery on Inspiratory Metaboreflex in Metabolically Healthy Obese and Obese Subjects With Metabolic Syndrome

The hypothesis of this study is that reductions in body weight could improve inspiratory muscle function attenuating the inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome.

Study Overview

• Status: Unknown
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Other: Bariatric surgery; Other: Control

Detailed Description

Introduction: Peripheral metaboreflex activation appears to be exacerbated in obese individuals with metabolic syndrome. Interestingly, bariatric surgery attenuates the peripheral metaboreflex. Obese individuals have impaired inspiratory muscle function, which can be reversed by the reduction in body weight. Therefore, bariatric surgery could attenuate inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome. Objectives: To investigate the effects of bariatric surgery on inspiratory metaboreflex in metabolically healthy obese individuals and in obese patients with metabolic syndrome. Patients and Methods: A sample comprising of 15 obese subjects with metabolic syndrome, 15 obese subjects without metabolic syndrome and 15 healthy nonobese individuals. These subjects will be submitted to pulmonary function, respiratory muscle strength, inspiratory muscle resistance, exercise tolerance, quality of life, autonomic cardiovascular control and the inspiratory metaboreflex evaluation. The evaluations performed in obese patients with and without metabolic syndrome pre-surgery will be repeated 6 months after bariatric surgery.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Cruz Alta, Rio Grande do Sul, Brazil, 9800050
      • Recruiting
      • University of Cruz Alta
      • Contact: Carine C Callegaro; Email: ccallegaro@unicruz.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obese subjects with metabolic syndrome, obese without metabolic syndrome and healthy nonobese subjects

Description

Obese with Metabolic Syndrome

Inclusion Criteria:

• Body mass index (BMI)> 35 kg / m²
• Diagnosis of metabolic syndrome

Exclusion Criteria:

• Acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions)
• Diseases of the nervous system or conditions that affect the understanding or participation in the study
• Pregnancy
• Type I diabetes mellitus
• Arterial hypertension
• Dyslipidemias
• Coronary artery disease
• Left ventricular dysfunction
• Any condition interfering with locomotion
• Bronchial asthma
• Chronic obstructive pulmonary disease
• Chronic neuropathies
• Use of drugs such as corticosteroids or bronchodilators
• Smokers.

Obese without Metabolic Syndrome

Inclusion Criteria:

• Body mass index (BMI)> 35 kg / m²

Exclusion Criteria:

• Metabolic Syndrome
• Acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions)
• Diseases of the nervous system or conditions that affect the understanding or participation in the study
• Pregnancy
• Type I diabetes mellitus
• Arterial hypertension
• Dyslipidemias
• Coronary artery disease
• Left ventricular dysfunction
• Any condition interfering with locomotion
• Bronchial asthma
• Chronic obstructive pulmonary disease
• Chronic neuropathies
• Use of drugs such as corticosteroids or bronchodilators
• Smokers.

Healthy nonobese subjects

Inclusion Criteria:

• BMI <25 kg / m²

Exclusion Criteria:

• Non-smokers
• Any diagnosed disease.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese with metabolic syndrome; bariatric surgery	Other: Bariatric surgery; evaluations pre and post bariatric surgery.
Obese without metabolic syndrome; bariatric surgery	Other: Bariatric surgery; evaluations pre and post bariatric surgery.
Healthy; Control	Other: Control; without intervention, it will be performed only evaluations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory metaboreflex	It will be induced through a linear inspiratory resistance of 60% of maximal inspiratory pressure	6 monhs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function	It will be assessed by spirometry	6 months
Respiratory muscle strength	It will be determined by manovacuometry.	6 months
Inspiratory muscle resistance	It will be evaluated through a protocol with progressive increase in inspiratory resistance.	6 months
Autonomic cardiovascular control	It will be determined by spectral analysis	6 months
Exercise tolerance	It will be determined by the 6-minute walk test.	6 months
Quality of life	It will be determined through the SF36 questionnaire.	6 months

Collaborators and Investigators

• Sponsor: University of Cruz Alta
• Investigators: Principal Investigator: Carine C Callegaro, PhD, University of Cruz Alta

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: CAAE: 51573315.7.0000.5322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No