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Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects

U

University of Cruz Alta

Status

Unknown

Conditions

Obesity
Metabolic Syndrome

Treatments

Other: Control
Other: Bariatric surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03056937
CAAE: 51573315.7.0000.5322

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

45 participants in 3 patient groups

Obese with metabolic syndrome
Description:
bariatric surgery
Treatment:
Other: Bariatric surgery
Obese without metabolic syndrome
Description:
bariatric surgery
Treatment:
Other: Bariatric surgery
Healthy
Description:
Control
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

Carine C Callegaro, PhD

Data sourced from clinicaltrials.gov

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