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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02409173
Other study ID # 742.865/2014
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date July 2020

Study information

Verified date June 2018
Source Centro Universitário de Anapolis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 17
Est. completion date July 2020
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Noninvasive positive airway pressure flow generator device
Noninvasive positive airway pressure flow generator device.
Procedure:
Bariatric Surgery
Standard Roux-en-Y gastric bypass

Locations

Country Name City State
Brazil Gastromed Anápolis GO
Brazil Department of Surgery of Santa Casa of Sao Paulo Medical School Sao Paulo SP
Brazil Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Centro Universitário de Anapolis

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in systemic immune response Systemic markers of inflammation through fasting blood samples biochemical indexes. Baseline immune response to 180 days.
Primary 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 Prevalence of sleep disorders Study sleep patterns through full standard polysomnography. 180 days
Secondary Changes in pulmonary function Assess pulmonary function through pletysmography. 180 days
Secondary Changes in maximal ventilatory pressures Assess maximal inspiratory and expiratory pressures through manovacuometry. 180 days
Secondary Changes in health related quality of life Changes in quality of life through Short Form-36 and BAROS questionnaires. 180 days
Secondary Weight Loss Body mass index reduction. 180 days
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