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 |
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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
Scientific
Oxford Centre for Respiratory Medicine
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Phone | +44 (0)1865 741841 |
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sophie@west66.freeserve.co.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | CPAP 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) studied | OSA and coexisting Type 2 diabetes |
Intervention | CPAP and Sham (placebo) CPAP |
Intervention type | Other |
Primary outcome measure | HbA1c% change |
Secondary outcome measures | Insulin resistance measured by euglycaemic clamp and homeostatic model assessment, blood pressure |
Overall study start date | 15/06/2004 |
Completion date | 19/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Male |
Target number of participants | 40 |
Key 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 |
Key exclusion criteria | 1. Unstable diabetes 2. Respiratory failure requiring urgent nocturnal ventilation |
Date of first enrolment | 15/06/2004 |
Date of final enrolment | 19/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
Diabetes UK
Charity
Charity
10 Parkway
London
NW1 7AA
United Kingdom
Phone | +44 (0)207 4241000 |
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info@diabetes.org.uk | |
Website | http://www.diabetes.org.uk |
https://ror.org/050rgn017 |
Funders
Funder type
Charity
Diabetes UK BDA:RD04/0002766 (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |