The Induction of IL-6 by NF-kB in PBMC in OSA (OSA)
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Apnea, Obstructive
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00498381
First Posted
July 8, 2007
Last Updated
July 8, 2007
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00498381
Brief Title
The Induction of IL-6 by NF-kB in PBMC in OSA
Acronym
OSA
Study Type
Interventional
2. Study Status
Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim of study:
To compare the level of IL-6 mRNA expression in peripheral blood monocytes between normal subjects and patients with OSAS
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-kB
To determine the effect of CPAP on the activation of NF-kB and IL-6 in peripheral blood monocytes in patients with moderate -severe OSAS
Detailed Description
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 NFB, 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- kB activation is associated with the level of IL-6 mRNA expression (3) CPAP therapy could lower both the activation of NF-kB and IL-6 mRNA expression in patients with moderate-severe OSAS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CPAP
Primary Outcome Measure Information:
Title
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.
Time Frame
patients evaluated before and in the end of four-week after CPAP treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hey-Dong Wu, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Induction of IL-6 by NF-kB in PBMC in OSA
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