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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Change in systemic adipose inflammation response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,
- •any cardiorespiratory condition opposite indicate the surgical procedure.
研究组 & 干预措施
Noninvasive Ventilation and Surgery
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
干预措施: Noninvasive positive airway pressure flow generator device (Device)
Noninvasive Ventilation and Surgery
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
干预措施: Bariatric Surgery (Procedure)
Control Group
结局指标
主要结局
Change in systemic adipose inflammation response
时间窗: Baseline adipose inflammation response to 180 days.
Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
Change in systemic immune response
时间窗: Baseline immune response to 180 days.
Systemic markers of inflammation through fasting blood samples biochemical indexes.
次要结局
- Changes in health related quality of life(180 days)
- Changes in pulmonary function(180 days)
- Prevalence of sleep disorders(180 days)
- Changes in maximal ventilatory pressures(180 days)
- Weight Loss(180 days)
研究者
Luis Vicente Franco de Oliveira
Professor
University of Nove de Julho