Obstructive Sleep Apnoea and Adipose Tissue Dysfunction

February 16, 2017 updated by: Katarina Kos, Royal Devon and Exeter NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Subjects with newly diagnosed obstructive sleep apnoea and controls

Description

Inclusion Criteria:

  • men with or without obstructive sleep apnoea

Exclusion Criteria:

  • weight loss interventions
  • steroid use
  • active smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
men with obstructive sleep apnoea
Continuous positive airway pressure devices
Device: Continuous positive airway pressure devices
overnight use of CPAP device
Other Names:
  • CPAP
control subjects
subjects with no obstructive sleep apnoea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pO2 in adipose tissue by Clarke type electrode
Time Frame: 4 months
Measurement of pO2 by Clarke type electrode
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood flow in adipose tissue by laser Doppler techniques
Time Frame: 4 months
assessment of tissue blood flow by laser Doppler techniques
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adipose tissue gene expression of HIF-1alpha
Time Frame: 4 months
adipose tissue expression of hypoxia related genes
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Collaborators

University of Exeter

Investigators

  • Principal Investigator: Katarina Kos, FRCP,PhD, University of Exeter

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSAadipose

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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