NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Device: Noninvasive positive airway pressure flow generator device
* Procedure: Bariatric Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive Ventilation and Surgery<br>Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery. | Device: Noninvasive positive airway pressure flow generator device<br>* Noninvasive positive airway pressure flow generator device.<br>* Other names: Noninvasive Positive Pressure Ventilation;Procedure: Bariatric Surgery<br>* Standard Roux-en-Y gastric bypass<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sleep disorders | Study sleep patterns through full standard polysomnography. | 180 days | 
| Changes in pulmonary function | Assess pulmonary function through pletysmography. | 180 days | 
| Changes in maximal ventilatory pressures | Assess maximal inspiratory and expiratory pressures through manovacuometry. | 180 days | 
| Changes in health related quality of life | Changes in quality of life through Short Form-36 and BAROS questionnaires. | 180 days | 
| Weight Loss | Body mass index reduction. | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, Sleep disorders, Bariatric Surgery, Noninvasive ventilation, Inflammation, Quality of life