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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17557769
Publication citations
-
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.