Condition category
Nervous System Diseases
Date applied
05/08/2005
Date assigned
14/09/2005
Last edited
25/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sophie West

ORCID ID

Contact details

Oxford Centre for Respiratory Medicine
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 741841
sophie@west66.freeserve.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/Q1605/5

Study information

Scientific title

Acronym

Study hypothesis

CPAP treatment for OSA in men with type 2 diabetes improves insulin resistance, glycaemic control and blood pressure.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

OSA and coexisting Type 2 diabetes

Intervention

CPAP and Sham (placebo) CPAP

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

HbA1c% change

Secondary outcome measures

Insulin resistance measured by euglycaemic clamp and homeostatic model assessment, blood pressure

Overall trial start date

15/06/2004

Overall trial end date

19/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-75
2. Type 2 diabetes
3. OSA with more than 10 >4% SaO2 dips per hour on sleep study
4. Epworth Sleepiness Score >9

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

40

Participant exclusion criteria

1. Unstable diabetes
2. Respiratory failure requiring urgent nocturnal ventilation

Recruitment start date

15/06/2004

Recruitment end date

19/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Diabetes UK

Sponsor details

10 Parkway
London
NW1 7AA
United Kingdom
+44 (0)207 4241000
info@diabetes.org.uk

Sponsor type

Charity

Website

http://www.diabetes.org.uk

Funders

Funder type

Charity

Funder name

Diabetes UK BDA:RD04/0002766 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17557769

Publication citations

  1. Results

    West SD, Nicoll DJ, Wallace TM, Matthews DR, Stradling JR, Effect of CPAP on insulin resistance and HbA1c in men with obstructive sleep apnoea and type 2 diabetes., Thorax, 2007, 62, 11, 969-974, doi: 10.1136/thx.2006.074351.

Additional files

Editorial Notes