Obstructive Sleep Apnoea and Adipose Tissue Dysfunction
Assessment of Hypoxia in Adipose Tissue of Subjects With Obstructive Sleep Apnoea
1 other identifier
observational
15
1 country
2
Brief Summary
Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFebruary 17, 2017
February 1, 2017
5 years
March 23, 2015
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pO2 in adipose tissue by Clarke type electrode
Measurement of pO2 by Clarke type electrode
4 months
Secondary Outcomes (1)
blood flow in adipose tissue by laser Doppler techniques
4 months
Other Outcomes (1)
adipose tissue gene expression of HIF-1alpha
4 months
Study Arms (2)
men with obstructive sleep apnoea
Continuous positive airway pressure devices
control subjects
subjects with no obstructive sleep apnoea
Interventions
overnight use of CPAP device
Eligibility Criteria
Subjects with newly diagnosed obstructive sleep apnoea and controls
You may qualify if:
- men with or without obstructive sleep apnoea
You may not qualify if:
- weight loss interventions
- steroid use
- active smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Devon and Exeter NHS Foundation Trustlead
- University of Exetercollaborator
Study Sites (2)
NIHR Clinical Research Facility
Exeter, EX25DW, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX25DW, United Kingdom
Related Publications (1)
Thorn CE, Knight B, Pastel E, McCulloch LJ, Patel B, Shore AC, Kos K. Adipose tissue is influenced by hypoxia of obstructive sleep apnea syndrome independent of obesity. Diabetes Metab. 2017 Jun;43(3):240-247. doi: 10.1016/j.diabet.2016.12.002. Epub 2017 Jan 26.
PMID: 28131740BACKGROUND
Biospecimen
adipose tissue and blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katarina Kos, FRCP,PhD
University of Exeter
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Physician
Study Record Dates
First Submitted
March 23, 2015
First Posted
August 10, 2015
Study Start
March 1, 2010
Primary Completion
March 1, 2015
Study Completion
November 1, 2015
Last Updated
February 17, 2017
Record last verified: 2017-02