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CompletedNCT02518633Updated Feb 17, 2017

Obstructive Sleep Apnoea and Adipose Tissue Dysfunction

An observational study in Obstructive Sleep Apnoea, Obesity and Hypoxia, sponsored by Royal Devon and Exeter NHS Foundation Trust. Completed at 2 sites in United Kingdom. Open to male participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by Royal Devon and Exeter NHS Foundation Trust · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 90 Years
Sex
Male
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Study 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.

Read the detailed description

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

02

Conditions studied

  • Obstructive Sleep Apnoea
  • Obesity
  • Hypoxia

Keywords

  • obesity
  • hypoxia
  • adipose tissue
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's enrollment of 15 is below the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Subjects with newly diagnosed obstructive sleep apnoea and controls

Inclusion criteria

  • men with or without obstructive sleep apnoea

Exclusion criteria

Exclusion Criteria:

  • weight loss interventions
  • steroid use
  • active smoking
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • men with obstructive sleep apnoea

    Continuous positive airway pressure devices

    Device: Continuous positive airway pressure devices

  • control subjects

    subjects with no obstructive sleep apnoea

Interventions

  • DeviceContinuous positive airway pressure devices

    overnight use of CPAP device

    Also known as: CPAP

06

What researchers measure

Primary outcomes

  1. pO2 in adipose tissue by Clarke type electrode

    Measurement of pO2 by Clarke type electrode

    Time frame: 4 months

Secondary outcomes

  1. blood flow in adipose tissue by laser Doppler techniques

    assessment of tissue blood flow by laser Doppler techniques

    Time frame: 4 months

Other outcomes

  1. adipose tissue gene expression of HIF-1alpha

    adipose tissue expression of hypoxia related genes

    Time frame: 4 months

07

Study locations

2 sites
  • NIHR Clinical Research Facility
    Exeter, EX25DW, United Kingdom
  • Royal Devon and Exeter NHS Foundation Trust
    Exeter, EX25DW, United Kingdom
08

References and documents

Publications

  • 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. PubMed 28131740 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02518633
Lead sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
University of Exeter
Responsible party
Katarina Kos (Consultant Physician, Royal Devon and Exeter NHS Foundation Trust) — Principal investigator
First posted
Aug 10, 2015
Start date
Mar 2010
Primary completion
Mar 2015
Completion
Nov 2015
Last update
Feb 17, 2017

Study contacts

Katarina Kos, FRCP,PhD
principal investigator · University of Exeter

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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