Obstructive Sleep Apnoea and Adipose Tissue Dysfunction | NCT02518633

Studies
Obstructive Sleep Apnoea and Adipose Tissue Dysfunction

NCT02518633

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Status

Completed

Last Update Posted

Feb 17, 2017Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnoea
Obesity
Hypoxia

Interventions

Continuous positive airway pressure devices

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2017

Last Update Posted Date

Feb 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katarina Kos, Consultant Physician, Royal Devon and Exeter NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Royal Devon and Exeter NHS Foundation TrustOTHER

Collaborators

Name	Class
University of Exeter	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Continuous positive airway pressure devices	Device	overnight use of CPAP device	men with obstructive sleep apnoea

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men with or without obstructive sleep apnoea

Exclusion Criteria:

weight loss interventions
steroid use
active smoking

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects with newly diagnosed obstructive sleep apnoea and controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katarina Kos, FRCP,PhD	University of Exeter	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NIHR Clinical Research Facility		Exeter		EX25DW	United Kingdom
Royal Devon and Exeter NHS Foundation Trust

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28131740	Background	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.

ID	Term
D020181	Sleep Apnea, Obstructive
D009765	Obesity
D000860	Hypoxia

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases