NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Noninvasive positive airway pressure flow generator device
Bariatric Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Sleep disorders, Bariatric Surgery, Noninvasive ventilation, Inflammation, Quality of life
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.
Sites / Locations
- Gastromed
- Department of Surgery of Santa Casa of Sao Paulo Medical School
- Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Noninvasive Ventilation and Surgery
Control Group
Arm Description
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
Outcomes
Primary Outcome Measures
Change in systemic immune response
Systemic markers of inflammation through fasting blood samples biochemical indexes.
Change in systemic adipose inflammation response
Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
Secondary Outcome Measures
Prevalence of sleep disorders
Study sleep patterns through full standard polysomnography.
Changes in pulmonary function
Assess pulmonary function through pletysmography.
Changes in maximal ventilatory pressures
Assess maximal inspiratory and expiratory pressures through manovacuometry.
Changes in health related quality of life
Changes in quality of life through Short Form-36 and BAROS questionnaires.
Weight Loss
Body mass index reduction.
Full Information
NCT ID
NCT02409173
First Posted
March 24, 2015
Last Updated
June 13, 2018
Sponsor
Centro Universitário de Anapolis
1. Study Identification
Unique Protocol Identification Number
NCT02409173
Brief Title
NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário de Anapolis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic syndrome, Sleep disorders, Bariatric Surgery, Noninvasive ventilation, Inflammation, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Noninvasive Ventilation and Surgery
Arm Type
Experimental
Arm Description
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Noninvasive positive airway pressure flow generator device
Other Intervention Name(s)
Noninvasive Positive Pressure Ventilation
Intervention Description
Noninvasive positive airway pressure flow generator device.
Intervention Type
Procedure
Intervention Name(s)
Bariatric Surgery
Intervention Description
Standard Roux-en-Y gastric bypass
Primary Outcome Measure Information:
Title
Change in systemic immune response
Description
Systemic markers of inflammation through fasting blood samples biochemical indexes.
Time Frame
Baseline immune response to 180 days.
Title
Change in systemic adipose inflammation response
Description
Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
Time Frame
Baseline adipose inflammation response to 180 days.
Secondary Outcome Measure Information:
Title
Prevalence of sleep disorders
Description
Study sleep patterns through full standard polysomnography.
Time Frame
180 days
Title
Changes in pulmonary function
Description
Assess pulmonary function through pletysmography.
Time Frame
180 days
Title
Changes in maximal ventilatory pressures
Description
Assess maximal inspiratory and expiratory pressures through manovacuometry.
Time Frame
180 days
Title
Changes in health related quality of life
Description
Changes in quality of life through Short Form-36 and BAROS questionnaires.
Time Frame
180 days
Title
Weight Loss
Description
Body mass index reduction.
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Gastromed
City
Anápolis
State/Province
GO
ZIP/Postal Code
75083-515
Country
Brazil
Facility Name
Department of Surgery of Santa Casa of Sao Paulo Medical School
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01221-010
Country
Brazil
Facility Name
Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01221010
Country
Brazil
12. IPD Sharing Statement
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NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
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