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The Induction of IL-6 by NF-kB in PBMC in OSA (OSA)

2007年7月8日 更新者:National Taiwan University Hospital

Aim of study:

  1. To compare the level of IL-6 mRNA expression in peripheral blood monocytes between normal subjects and patients with OSAS
  2. To compare the activation of NF-B in peripheral blood monocytes between control subjects and patients with OSAS; Check the correlation between level of L-6 mRNA expression and activation of NF-kB
  3. To determine the effect of CPAP on the activation of NF-kB and IL-6 in peripheral blood monocytes in patients with moderate -severe OSAS

研究概览

地位

完全的

干预/治疗

详细说明

Obstructive sleep apnea syndrome (OSAS) has emerged in recent years as an important risk factor for cardiovascular morbidity. The mechanisms responsible for developments of cardiovascular sequelae in patients with OSA include hypoxia, hypercapnia, exaggerated negative intrathoracic pressure and bursts of sympathetic activity provoking surges in blood pressure and heart rate. Meanwhile, increase of inflammatory mediators, which included C-reactive protein (CRP), oxidative stress, adhesion molecules, vascular endothelial growth factor (VEGF) and proinflammatory cytokines (interleukin (IL) -1, IL-2, IL-6, IL-8, IL-10 and tumor necrotic factor- (TNF-)), also involve in the development of cardiovascular disease in patients with OSAS.

According to our preliminary study, serum levels of IL-6 and CRP were higher in patients with OSAS than control subjects and levels of both IL-6 and CRP were highly correlated with the lowest pulse oxygen saturation. Hypoxia triggered the production of IL-6 through the induction of NFB, which was demonstrated in ischemic heart disease and pancreatitis. However, this mechanism has not been prooved in OSAS.

Therefore, we conduct this study to prove our hypothesis (1) The mRNA expression of IL-6 in peripheral blood monocytes was significantly higher in patients with OSAS than control subjects (2) The activation of NF-k B in peripheral blood monocytes was more significant in patients with OSAS than control subjects, and the level of NF- kB activation is associated with the level of IL-6 mRNA expression (3) CPAP therapy could lower both the activation of NF-kB and IL-6 mRNA expression in patients with moderate-severe OSAS.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  • severe obstructive sleep apnea (AHI>=30 /hr) male older than 18 y/o

Exclusion Criteria:

  • refuse participate, chronic lung disease active infection neurologic event

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:基础科学
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The levels of IL-6 mRNA expression and activation of NF-B in peripheral blood monocytes were higher in OSA patients than normal subjects. And increased IL-6 mRNA expression and activation of NF-B go down after 4-week CPAP treatment.
大体时间:patients evaluated before and in the end of four-week after CPAP treatment
patients evaluated before and in the end of four-week after CPAP treatment

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:Hey-Dong Wu, M.D.、National Taiwan University Hospital

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

2005年8月1日

研究完成 (实际的)

2006年8月1日

研究注册日期

首次提交

2007年7月8日

首先提交符合 QC 标准的

2007年7月8日

首次发布 (估计)

2007年7月10日

研究记录更新

最后更新发布 (估计)

2007年7月10日

上次提交的符合 QC 标准的更新

2007年7月8日

最后验证

2005年2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.

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