Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects
1 other identifier
observational
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 17, 2017
February 1, 2017
1.8 years
February 14, 2017
February 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Inspiratory metaboreflex
It will be induced through a linear inspiratory resistance of 60% of maximal inspiratory pressure
6 monhs
Secondary Outcomes (6)
Pulmonary function
6 months
Respiratory muscle strength
6 months
Inspiratory muscle resistance
6 months
Autonomic cardiovascular control
6 months
Exercise tolerance
6 months
- +1 more secondary outcomes
Study Arms (3)
Obese with metabolic syndrome
bariatric surgery
Obese without metabolic syndrome
bariatric surgery
Healthy
Control
Interventions
evaluations pre and post bariatric surgery.
Eligibility Criteria
Obese subjects with metabolic syndrome, obese without metabolic syndrome and healthy nonobese subjects
You may qualify if:
- Body mass index (BMI)\> 35 kg / m²
- Diagnosis of metabolic syndrome
You may not qualify if:
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cruz Alta
Cruz Alta, Rio Grande do Sul, 9800050, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carine C Callegaro, PhD
University of Cruz Alta
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 17, 2017
Study Start
February 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
February 17, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share