ObesityNCT03056937
Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects
An observational study of Obesity and Metabolic Syndrome, run by University of Cruz Alta at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Bariatric surgery
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2016to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Obese subjects with metabolic syndrome, obese without metabolic syndrome and healthy nonobese subjects
Who may be able to join
- Body mass index (BMI)> 35 kg / m²
- Diagnosis of metabolic syndrome
- Body mass index (BMI)> 35 kg / m²
- BMI <25 kg / m²
Who cannot join
- 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
Show all 33Show fewer
- 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
- 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
- Non-smokers
- Any diagnosed disease.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Cruz Alta
Cruz Alta, Rio Grande do Sul, 9800050
Carine C Callegaro, ccallegaro@unicruz.edu.br
About this study
Official title: Effects of Bariatric Surgery on Inspiratory Metaboreflex in Metabolically Healthy Obese and Obese Subjects With Metabolic Syndrome
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.
Read the 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.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Bariatric surgery, Control
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryOther
evaluations pre and post bariatric surgery.
ControlOther
without intervention, it will be performed only evaluations
| Study group | Role | What they receive |
|---|---|---|
| Obese with metabolic syndrome | bariatric surgery Receives: Other: Bariatric surgery | |
| Obese without metabolic syndrome | bariatric surgery Receives: Other: Bariatric surgery | |
| Healthy | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory metaboreflex
It will be induced through a linear inspiratory resistance of 60% of maximal inspiratory pressure
Measured: 6 monhs
Secondary outcomes (6)
Pulmonary function
It will be assessed by spirometry
Measured: 6 months
Respiratory muscle strength
It will be determined by manovacuometry.
Measured: 6 months
Inspiratory muscle resistance
It will be evaluated through a protocol with progressive increase in inspiratory resistance.
Measured: 6 months
Autonomic cardiovascular control
It will be determined by spectral analysis
Measured: 6 months
Exercise tolerance
It will be determined by the 6-minute walk test.
Measured: 6 months
Quality of life
It will be determined through the SF36 questionnaire.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start1 Feb 2016
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cruz Alta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine C Callegaro, PhD, Principal investigator, University of Cruz Alta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056937
- Sponsor's protocol ID
- CAAE: 51573315.7.0000.5322
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on Inspiratory Metaboreflex in Metabolically Healthy Obese and Obese Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03056937
- Acronym / sponsor ID
- CAAE: 51573315.7.0000.5322
- Conditions
- Obesity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Cruz AltaUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese with metabolic syndrome | – | Other: Bariatric surgerybariatric surgery |
| Obese without metabolic syndrome | – | Other: Bariatric surgerybariatric surgery |
| Healthy | – | Other: ControlControl |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obese subjects with metabolic syndrome, obese without metabolic syndrome and healthy nonobese subjects
Key inclusion criteria (4 listed)
- Body mass index (BMI)> 35 kg / m²
- Diagnosis of metabolic syndrome
- Body mass index (BMI)> 35 kg / m²
- BMI <25 kg / m²
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryevaluations pre and post bariatric surgery. | Other | Obese with metabolic syndrome, Obese without metabolic syndrome |
| Controlwithout intervention, it will be performed only evaluations | Other | Healthy |
Primary outcome
Inspiratory metaboreflex
Time frame: 6 monhs
It will be induced through a linear inspiratory resistance of 60% of maximal inspiratory pressure
6 secondary outcomes
Pulmonary function
Time frame: 6 months
Respiratory muscle strength
Time frame: 6 months
Inspiratory muscle resistance
Time frame: 6 months
Autonomic cardiovascular control
Time frame: 6 months
Exercise tolerance
Time frame: 6 months
Quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carine C Callegaro, PhD principal investigator
University of Cruz Alta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by University of Cruz Alta at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carine C Callegaro, PhD (+55 (55) 99914-6712, ccallegaro@unicruz.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory metaboreflex (time frame: 6 monhs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.