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

NCT ID: NCT02409173

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Noninvasive Ventilation and Surgery

Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.

Group Type: EXPERIMENTAL

Noninvasive positive airway pressure flow generator device

Intervention Type: DEVICE

Noninvasive positive airway pressure flow generator device.

Bariatric Surgery

Intervention Type: PROCEDURE

Standard Roux-en-Y gastric bypass

Interventions

Noninvasive positive airway pressure flow generator device

Noninvasive positive airway pressure flow generator device.

Intervention Type: DEVICE

Bariatric Surgery

Standard Roux-en-Y gastric bypass

Intervention Type: PROCEDURE

Other Intervention Names

Noninvasive Positive Pressure Ventilation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Universitário de Anapolis

OTHER

Sponsor Role: lead

Responsible Party

Luis Vicente Franco de Oliveira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gastromed

Anápolis, Goiás, Brazil

Department of Surgery of Santa Casa of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

742.865/2014

Identifier Type: -

Identifier Source: org_study_id