NCT02518633

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

5 years

First QC Date

March 23, 2015

Last Update Submit

February 16, 2017

Conditions

Keywords

obesityhypoxiaadipose tissue

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

Device: Continuous positive airway pressure devices

control subjects

subjects with no obstructive sleep apnoea

Interventions

overnight use of CPAP device

Also known as: CPAP
men with obstructive sleep apnoea

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (2)

NIHR Clinical Research Facility

Exeter, EX25DW, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX25DW, United Kingdom

Location

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

Retention: SAMPLES WITHOUT DNA

adipose tissue and blood samples

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesityHypoxia

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Respiratory

Study Officials

  • Katarina Kos, FRCP,PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

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

Locations