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Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056937
Recruitment Status : Unknown
Verified February 2017 by University of Cruz Alta.
Recruitment status was:  Recruiting
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Cruz Alta

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.

Condition or disease Intervention/treatment
Obesity Metabolic Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Bariatric Surgery on Inspiratory Metaboreflex in Metabolically Healthy Obese and Obese Subjects With Metabolic Syndrome
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Inspiratory metaboreflex [ Time Frame: 6 monhs ]
    It will be induced through a linear inspiratory resistance of 60% of maximal inspiratory pressure


Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: 6 months ]
    It will be assessed by spirometry

  2. Respiratory muscle strength [ Time Frame: 6 months ]
    It will be determined by manovacuometry.

  3. Inspiratory muscle resistance [ Time Frame: 6 months ]
    It will be evaluated through a protocol with progressive increase in inspiratory resistance.

  4. Autonomic cardiovascular control [ Time Frame: 6 months ]
    It will be determined by spectral analysis

  5. Exercise tolerance [ Time Frame: 6 months ]
    It will be determined by the 6-minute walk test.

  6. Quality of life [ Time Frame: 6 months ]
    It will be determined through the SF36 questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese subjects with metabolic syndrome, obese without metabolic syndrome and healthy nonobese subjects
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056937


Contacts
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Contact: Carine C Callegaro, PhD +55 (55) 99914-6712 ccallegaro@unicruz.edu.br

Locations
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Brazil
University of Cruz Alta Recruiting
Cruz Alta, Rio Grande do Sul, Brazil, 9800050
Contact: Carine C Callegaro       ccallegaro@unicruz.edu.br   
Sponsors and Collaborators
University of Cruz Alta
Investigators
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Principal Investigator: Carine C Callegaro, PhD University of Cruz Alta
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Responsible Party: University of Cruz Alta
ClinicalTrials.gov Identifier: NCT03056937    
Other Study ID Numbers: CAAE: 51573315.7.0000.5322
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases