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

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Device: Noninvasive positive airway pressure flow generator device; Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • GO
    • Anápolis, GO, Brazil, 75083-515
      • Gastromed
  • SP
    • Sao Paulo, SP, Brazil, 01221-010
      • Department of Surgery of Santa Casa of Sao Paulo Medical School
    • Sao Paulo, SP, Brazil, 01221010
      • Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centro Universitário de Anapolis

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Metabolic syndrome; Quality of life; Sleep disorders; Bariatric Surgery; Noninvasive ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 742.865/2014