NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
2018年6月13日 更新者:Luis Vicente Franco de Oliveira、Centro Universitário de Anapolis
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.
研究概览
地位
未知
条件
详细说明
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.
研究类型
介入性
注册 (预期的)
17
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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GO
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Anápolis、GO、巴西、75083-515
- Gastromed
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SP
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Sao Paulo、SP、巴西、01221-010
- Department of Surgery of Santa Casa of Sao Paulo Medical School
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Sao Paulo、SP、巴西、01221010
- Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:控制组
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实验性的:Noninvasive Ventilation and Surgery
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
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Noninvasive positive airway pressure flow generator device.
其他名称:
Standard Roux-en-Y gastric bypass
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in systemic immune response
大体时间:Baseline immune response to 180 days.
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Systemic markers of inflammation through fasting blood samples biochemical indexes.
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Baseline immune response to 180 days.
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Change in systemic adipose inflammation response
大体时间:Baseline adipose inflammation response to 180 days.
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Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
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Baseline adipose inflammation response to 180 days.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of sleep disorders
大体时间:180 days
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Study sleep patterns through full standard polysomnography.
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180 days
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Changes in pulmonary function
大体时间:180 days
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Assess pulmonary function through pletysmography.
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180 days
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Changes in maximal ventilatory pressures
大体时间:180 days
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Assess maximal inspiratory and expiratory pressures through manovacuometry.
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180 days
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Changes in health related quality of life
大体时间:180 days
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Changes in quality of life through Short Form-36 and BAROS questionnaires.
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180 days
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Weight Loss
大体时间:180 days
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Body mass index reduction.
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180 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年1月1日
初级完成 (实际的)
2018年5月1日
研究完成 (预期的)
2020年7月1日
研究注册日期
首次提交
2015年3月24日
首先提交符合 QC 标准的
2015年4月3日
首次发布 (估计)
2015年4月6日
研究记录更新
最后更新发布 (实际的)
2018年6月15日
上次提交的符合 QC 标准的更新
2018年6月13日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
代谢综合征的临床试验
-
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