Obstructive Sleep Apnoea (OSA) in patients with type 2 diabetes and the effect of continuous positive airway pressure (CPAP) treatment on diabetic control, insulin resistance and blood pressure

ISRCTN ISRCTN28644636
DOI https://doi.org/10.1186/ISRCTN28644636
Secondary identifying numbers 04/Q1605/5
Submission date
05/08/2005
Registration date
14/09/2005
Last edited
25/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sophie West
Scientific

Oxford Centre for Respiratory Medicine
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Phone +44 (0)1865 741841
Email sophie@west66.freeserve.co.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesCPAP treatment for OSA in men with type 2 diabetes improves insulin resistance, glycaemic control and blood pressure.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOSA and coexisting Type 2 diabetes
InterventionCPAP and Sham (placebo) CPAP
Intervention typeOther
Primary outcome measureHbA1c% change
Secondary outcome measuresInsulin resistance measured by euglycaemic clamp and homeostatic model assessment, blood pressure
Overall study start date15/06/2004
Completion date19/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexMale
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. Unstable diabetes
2. Respiratory failure requiring urgent nocturnal ventilation
Date of first enrolment15/06/2004
Date of final enrolment19/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Diabetes UK
Charity

10 Parkway
London
NW1 7AA
United Kingdom

Phone +44 (0)207 4241000
Email info@diabetes.org.uk
Website http://www.diabetes.org.uk
ROR logo "ROR" https://ror.org/050rgn017

Funders

Funder type

Charity

Diabetes UK BDA:RD04/0002766 (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2007 Yes No