Weight Loss and Obstructive Sleep Apnea
2014年7月30日 更新者:Antonio Felipe Sanjuliani、Rio de Janeiro State University
Effects of Energy Restriction on Sleep Apnea, Sympathetic Activity, Oxidative Stress, Inflammatory Biomarkers, Endothelial Function, Body Adiposity, Metabolic Profile and Blood Pressure in Obese Patients With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effects of moderate energy restriction on the body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress, inflammatory biomarkers, metabolic profile and endothelial function in obese patients with OSA.
研究概览
详细说明
Introduction: Nutritional intervention for weight loss is one of the treatment options for obstructive sleep apnea (OSA) in patients with excess body adiposity.
However, the effects of moderate energy restriction, recommended by current guidelines for the treatment of obesity, on OSA are not yet known.
Objective: To evaluate the effects of moderate energy restriction on the body adiposity; severity of OSA; blood pressure; sympathetic activity; oxidative stress; inflammatory biomarkers; metabolic profile and endothelial function in obese patients with OSA.
Methods: A 16-week randomized clinical trial, involving 21 subjects with obesity (grade I or II), aged 20-55 years and presenting an apnea/hipopnea index (AHI) > 5 events/h.
Participants were randomized into 2 groups: 11 in the energy restriction group (ERG) and 10 in the control group (CG).
The ERG was instructed to follow an energy-restricted diet (-800 kcal/day) and the CG was advised not to change their food intake.
At the beginning and at the end of the study, participants underwent evaluation of: OSA with the equipment Watch- PAT200® including the determination of the following parameters of OSA severity: AHI, minimum O2 saturation, number of O2 desaturations >4%; body adiposity (weight, %body fat and circumferences of waist, hip and neck); blood pressure (BP); sympathetic nervous system activity (plasma levels of catecholamines); inflammatory biomarkers (c-reactive protein and adiponectin); oxidative stress (malondialdehyde); metabolism of glucose (glucose, insulin and HOMA-IR) and lipids (total cholesterol and fractions and triglycerides); and endothelial function (index of reactive hyperemia evaluated by Endo - PAT 2000® and cellular adhesion molecules).
The statistical analysis was performed with the software STATA v. 10.
The level of statistical significance was p < 0.05.
研究类型
介入性
注册 (实际的)
21
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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-
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Rio de Janeiro、巴西、20.551-030
- Discipline of Clinical and Experimental Pathophysiology, CLINEX
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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
20年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age between 20-55 years
- body mass index (BMI) ≥ 30 kg/m2 and < 40 kg/m2
Exclusion Criteria:
- smoking
- Use of dietary supplements
- Use of medications that could interfere in body weight, metabolic profile and blood pressure
- Use of permanent pacemaker; use of α-adrenergic blocking agents
- Recent changes (within previous 6 months) in body weight (> 3 kg), in dietary intake and in intensity or frequency of physical exercise
- Diagnosis of diabetes mellitus, hypertension, dyslipidemia (with drug treatment) and kidney disease
- Clinical history of thyroid dysfunction, angina pectoris, peripheral vascular disease, peripheral neuropathy, heart failure, liver failure, chronic pulmonary disease, gastroesophageal reflux disease, myocardial infarction and stroke; finger deformity that prevents the proper use of the sensors that are necessary to evaluate OSA and endothelial function; and previous bilateral cervical-thoracic sympathectomy
- Pregnant or lactating women were not allowed into the study
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Energy restriction group
The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
|
The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
|
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无干预:Control group
The control group was advised not to change their food intake.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Apnea/hipopnea index
大体时间:16 weeks
|
16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
血压
大体时间:16周
|
16周
|
|
|
Sympathetic activity
大体时间:16 weeks
|
Plasma levels of catecholamines
|
16 weeks
|
|
Oxidative stress
大体时间:16 weeks
|
Serum levels of malondialdehyde
|
16 weeks
|
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Inflammatory biomarkers
大体时间:16 weeks
|
Circulating levels of high-sensitivity C reactive protein and adiponectin
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16 weeks
|
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Metabolic profile
大体时间:16 weeks
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Fasting plasma glucose, insulin, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides
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16 weeks
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Endothelial function
大体时间:16 weeks
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Circulating levels of cellular adhesion molecules (intercellular adhesion molecule 1 and P-selectin). Endothelial function was also evaluated by the PAT method, using Endo-PAT 2000®. |
16 weeks
|
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。
调查人员
- 首席研究员:Antonio Felipe Sanjuliani, Dr.、Rio de Janeiro State University
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
2012年3月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2014年6月27日
首先提交符合 QC 标准的
2014年7月30日
首次发布 (估计)
2014年8月1日
研究记录更新
最后更新发布 (估计)
2014年8月1日
上次提交的符合 QC 标准的更新
2014年7月30日
最后验证
2014年7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.