Obstructive Sleep Apnoea and Adipose Tissue Dysfunction

Obesity Clinical Trial

Official title:

Assessment of Hypoxia in Adipose Tissue of Subjects With Obstructive Sleep Apnoea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518633
• Other study ID #: OSAadipose
• 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
• 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

Related Conditions & MeSH terms

• Anoxia
• Apnea
• Hypoxia
• Obesity
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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