Metabolic SyndromeNCT02409173
NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
A study testing Noninvasive positive airway pressure flow generator device and Bariatric Surgery in people with Metabolic Syndrome, run by Centro Universitário de Anapolis at 3 sites in Brazil.
Trial summary
Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Noninvasive positive airway pressure flow generator device and Bariatric Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2015to Jul 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients aged 18 to 65 years,
- grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities,
- awaiting bariatric surgery,
- with documented history of conventional weight loss attempts having proven unsuccessful over time,
- sleep apnea history verified through polysomnography
- and if they are able to understand and agreement to participate in the study through a signed term of informed consent.
Who cannot join
- Any medical condition rendering surgery too risky,
- BMI above 55 kg/m2,
- unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment,
- pregnancy,
- lactation or planned pregnancy within two years of potential surgical treatment,
- lack of safe access to abdominal cavity or gastrointestinal tract;
Show all 11Show fewer
- abusive alcohol use or drug use,
- craniofacial abnormalities,
- undergoing active treatment of sleep apnea,
- cancer,
- any cardiorespiratory condition opposite indicate the surgical procedure.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Gastromed
Anápolis, Goiás, 75083-515
Department of Surgery of Santa Casa of Sao Paulo Medical School
São Paulo, São Paulo, 01221-010
Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School
São Paulo, São Paulo, 01221010
About this study
Official title: Effects of Noninvasive Positive Pressure Ventilation on Inflammatory Markers, Sleep, Pulmonary Function and HRQoL in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery. A Randomized Controlled Clinical Trial
Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS. It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery.
Read the detailed description
Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS. It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery. Methods/Design: Will participate severe obese patients with and without MS, screened from the Bariatric Surgery Service of Santa Casa de Sao Paulo. The inclusion criteria are patients with morbid obesity grade III, with an indication of bariatric surgery and who have agreed to the study, signing an informed consent. Subjects with BMI above 55 kg / m², clinically significant or mental health concerns unstable, an unrealistic target postsurgical weight and/or unrealistic expectations of the surgical treatment will be excluded. Patients will use the NPPV pre and post bariatric surgery. The evaluation protocol will consist of clinical history, vital signs, anthropometric data, clinical analysis of blood and adipose inflammatory markers, lung function tests, polysomnography, sleep scales, cardiovascular risk and quality of life questionnaires. Patients will be evaluated before and after bariatric surgery, 90, 180 and 360 days.
- Conditions
- Metabolic Syndrome
- Being tested
- Noninvasive positive airway pressure flow generator device, Bariatric Surgery
- Keywords
- Metabolic syndrome, Sleep disorders, Bariatric Surgery, Noninvasive ventilation, Inflammation, Quality of life
- Medical subject headings
- Metabolic Syndrome, Sleep Wake Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive positive airway pressure flow generator deviceDevice
Also called Noninvasive Positive Pressure Ventilation
Noninvasive positive airway pressure flow generator device.
Bariatric SurgeryProcedure or surgery
Standard Roux-en-Y gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Ventilation and Surgery | Experimental | Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery. Receives: Device: Noninvasive positive airway pressure flow generator device; Procedure: Bariatric Surgery |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systemic immune response
Systemic markers of inflammation through fasting blood samples biochemical indexes.
Measured: Baseline immune response to 180 days.
Change in systemic adipose inflammation response
Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
Measured: Baseline adipose inflammation response to 180 days.
Secondary outcomes (5)
Prevalence of sleep disorders
Study sleep patterns through full standard polysomnography.
Measured: 180 days
Changes in pulmonary function
Assess pulmonary function through pletysmography.
Measured: 180 days
Changes in maximal ventilatory pressures
Assess maximal inspiratory and expiratory pressures through manovacuometry.
Measured: 180 days
Changes in health related quality of life
Changes in quality of life through Short Form-36 and BAROS questionnaires.
Measured: 180 days
Weight Loss
Body mass index reduction.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2018
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário de Anapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Vicente Franco de Oliveira, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409173
- Sponsor's protocol ID
- 742.865/2014
- Status last verified
- Jun 2018
- First submitted
- 24 Mar 2015
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Noninvasive Positive Pressure Ventilation on Inflammatory Markers, Sleep, Pulmonary Function and HRQoL in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02409173
- Acronym / sponsor ID
- 742.865/2014
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Sleep disorders, Bariatric Surgery, Noninvasive ventilation, Inflammation, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Centro Universitário de AnapolisUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 6 Apr 2015 (estimated)
- 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.
Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS. It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery.
Detailed description
Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS. It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery. Methods/Design: Will participate severe obese patients with and without MS, screened from the Bariatric Surgery Service of Santa Casa de Sao Paulo. The inclusion criteria are patients with morbid obesity grade III, with an indication of bariatric surgery and who have agreed to the study, signing an informed consent. Subjects with BMI above 55 kg / m², clinically significant or mental health concerns unstable, an unrealistic target postsurgical weight and/or unrealistic expectations of the surgical treatment will be excluded. Patients will use the NPPV pre and post bariatric surgery. The evaluation protocol will consist of clinical history, vital signs, anthropometric data, clinical analysis of blood and adipose inflammatory markers, lung function tests, polysomnography, sleep scales, cardiovascular risk and quality of life questionnaires. Patients will be evaluated before and after bariatric surgery, 90, 180 and 360 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Ventilation and Surgery | Experimental | Device: Noninvasive positive airway pressure flow generator device, Procedure: Bariatric SurgeryNoninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male and female patients aged 18 to 65 years,
- grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities,
- awaiting bariatric surgery,
- with documented history of conventional weight loss attempts having proven unsuccessful over time,
- sleep apnea history verified through polysomnography
Key exclusion criteria (11 listed)
- Any medical condition rendering surgery too risky,
- BMI above 55 kg/m2,
- unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment,
- pregnancy,
- lactation or planned pregnancy within two years of potential surgical treatment,
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 |
|---|---|---|
| Noninvasive positive airway pressure flow generator deviceAlso: Noninvasive Positive Pressure VentilationNoninvasive positive airway pressure flow generator device. | Device | Noninvasive Ventilation and Surgery |
| Bariatric SurgeryStandard Roux-en-Y gastric bypass | Procedure or surgery | Noninvasive Ventilation and Surgery |
Primary outcome
Change in systemic immune response
Time frame: Baseline immune response to 180 days.
Systemic markers of inflammation through fasting blood samples biochemical indexes.
Change in systemic adipose inflammation response
Time frame: Baseline adipose inflammation response to 180 days.
Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
5 secondary outcomes
Prevalence of sleep disorders
Time frame: 180 days
Changes in pulmonary function
Time frame: 180 days
Changes in maximal ventilatory pressures
Time frame: 180 days
Changes in health related quality of life
Time frame: 180 days
Weight Loss
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive positive airway pressure flow generator device and Bariatric Surgery in people with Metabolic Syndrome, run by Centro Universitário de Anapolis at 3 sites 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 6 inclusion and 11 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic immune response (time frame: Baseline immune response to 180 days.). The study lists 2 primary outcomes in all. 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 15 Jun 2018.