NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
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
1 other identifier
interventional
17
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
3 active sites
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
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJune 15, 2018
June 1, 2018
3.3 years
March 24, 2015
June 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in systemic immune response
Systemic markers of inflammation through fasting blood samples biochemical indexes.
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.
Baseline adipose inflammation response to 180 days.
Secondary Outcomes (5)
Prevalence of sleep disorders
180 days
Changes in pulmonary function
180 days
Changes in maximal ventilatory pressures
180 days
Changes in health related quality of life
180 days
Weight Loss
180 days
Study Arms (2)
Noninvasive Ventilation and Surgery
EXPERIMENTALNoninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
Control Group
NO INTERVENTIONInterventions
Noninvasive positive airway pressure flow generator device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- abusive alcohol use or drug use,
- craniofacial abnormalities,
- undergoing active treatment of sleep apnea,
- cancer,
- any cardiorespiratory condition opposite indicate the surgical procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Gastromed
Anápolis, Goiás, 75083-515, Brazil
Department of Surgery of Santa Casa of Sao Paulo Medical School
São Paulo, São Paulo, 01221-010, Brazil
Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School
São Paulo, São Paulo, 01221010, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 24, 2015
First Posted
April 6, 2015
Study Start
January 1, 2015
Primary Completion
May 1, 2018
Study Completion
July 1, 2020
Last Updated
June 15, 2018
Record last verified: 2018-06