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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02518633
Other study ID # OSAadipose
Secondary ID
Status Completed
Phase N/A
First received March 23, 2015
Last updated February 16, 2017
Start date March 2010
Est. completion date November 2015

Study information

Verified date February 2017
Source Royal Devon and Exeter NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Assessment includes a adipose tissue biopsy and measurement of oxygenation and blood flow by a Clarke type electrodes and non-invasive Doppler techniques.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- men with or without obstructive sleep apnoea

Exclusion Criteria:

- weight loss interventions

- steroid use

- active smoking

Study Design


Intervention

Device:
Continuous positive airway pressure devices
overnight use of CPAP device

Locations

Country Name City State
United Kingdom NIHR Clinical Research Facility Exeter
United Kingdom Royal Devon and Exeter NHS Foundation Trust Exeter

Sponsors (2)

Lead Sponsor Collaborator
Royal Devon and Exeter NHS Foundation Trust University of Exeter

Country where clinical trial is conducted

United Kingdom, 

References & 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 Jan 25. pii: S1262-3636(16)30567-5. doi: 10.1016/j.diabet.2016.12.002. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other adipose tissue gene expression of HIF-1alpha adipose tissue expression of hypoxia related genes 4 months
Primary pO2 in adipose tissue by Clarke type electrode Measurement of pO2 by Clarke type electrode 4 months
Secondary blood flow in adipose tissue by laser Doppler techniques assessment of tissue blood flow by laser Doppler techniques 4 months
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