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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	HbA1c% change
Key secondary outcome measure(s)	Insulin resistance measured by euglycaemic clamp and homeostatic model assessment, blood pressure
Completion date	19/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Male
Target sample size at registration	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

Oxford Centre for Respiratory Medicine

Oxford
OX3 7LJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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