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

This study has been completed.

Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00498381
  Purpose

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

Condition Intervention
Sleep Apnea, Obstructive
Device: CPAP

MedlinePlus related topics:   Sleep Apnea   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Non-Randomized, Open Label, Active Control, Single Group Assignment

Further study details as provided by National Taiwan University Hospital:

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. [ Time Frame: patients evaluated before and in the end of four-week after CPAP treatment ]

Enrollment:   20
Study Start Date:   August 2005
Study Completion Date:   August 2006

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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498381

Sponsors and Collaborators
National Taiwan University Hospital

Investigators
Principal Investigator:     Hey-Dong Wu, M.D.     National Taiwan University Hospital    
  More Information


Study ID Numbers:   9361701235
First Received:   July 8, 2007
Last Updated:   July 8, 2007
ClinicalTrials.gov Identifier:   NCT00498381
Health Authority:   Taiwan: Department of Health

Study placed in the following topic categories:
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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