Clinical trial NCT03056937: Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects
Official title: Effects of Bariatric Surgery on Inspiratory Metaboreflex in Metabolically Healthy Obese and Obese Subjects With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Metabolic Syndrome
Lead sponsor: University of Cruz Alta
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese subjects with metabolic syndrome, obese without metabolic syndrome and healthy nonobese subjects

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inspiratory metaboreflex
timeFrame: 6 monhs
Secondary outcomes:
measure: Pulmonary function
timeFrame: 6 months
measure: Respiratory muscle strength
timeFrame: 6 months
measure: Inspiratory muscle resistance
timeFrame: 6 months
measure: Autonomic cardiovascular control
timeFrame: 6 months
measure: Exercise tolerance
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Cruz Alta
country: Brazil
facility: University of Cruz Alta
state: Rio Grande do Sul
Study officials:
affiliation: University of Cruz Alta
name: Carine C Callegaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: