Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03056937
• Other study ID #: CAAE: 51573315.7.0000.5322
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2017
• Last updated: February 14, 2017
• Start date: February 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2017
• Source: University of Cruz Alta
• Contact: Carine C Callegaro, PhD
• Phone: +55 (55) 99914-6712
• Email: ccallegaro[@]unicruz.edu.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

Other:
• Bariatric surgery
evaluations pre and post bariatric surgery.
• Control
without intervention, it will be performed only evaluations

Locations

Country	Name	City	State
Brazil	University of Cruz Alta	Cruz Alta	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
University of Cruz Alta

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory metaboreflex	It will be induced through a linear inspiratory resistance of 60% of maximal inspiratory pressure	6 monhs
Secondary	Pulmonary function	It will be assessed by spirometry	6 months
Secondary	Respiratory muscle strength	It will be determined by manovacuometry.	6 months
Secondary	Inspiratory muscle resistance	It will be evaluated through a protocol with progressive increase in inspiratory resistance.	6 months
Secondary	Autonomic cardiovascular control	It will be determined by spectral analysis	6 months
Secondary	Exercise tolerance	It will be determined by the 6-minute walk test.	6 months
Secondary	Quality of life	It will be determined through the SF36 questionnaire.	6 months