CPAP with or without liraglutide in sleep apnoea and diabetes
Research type
Research Study
Full title
A randomized, controlled multi-centre trial of 26 weeks of subcutaneous Liraglutide (a GLP1 receptor agonist), with or without continuous positive airway pressure (CPAP), in patients with Type 2 Diabetes Mellitus (T2DM) and Obstructive Sleep Apnoea (OSA)
IRAS ID
132823
Contact name
Daniel Cuthbertson
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2014-000988-41
Research summary
Obstructive sleep apnoea (OSA) is a disorder characterised by repeated closing of the upper airway during sleep and can cause snoring, waking during sleep and periods of blocked airflow. There is a particularly high prevalence of OSA in obese patients with type 2 diabetes mellitus (T2DM) (~86%). If effective treatment is not administered, OSA can infer significant long-term health risks. Current treatment options for OSA include weight loss, via a very low energy diet, intensive lifestyle intervention or metabolic surgery, or, in the absence of weight loss, continuous positive airway pressure (CPAP) facilitates normal breathing patterns during sleep by splinting the upper airway open. Thus beneficial effects of treatment may be derived from a mechanical and/or a metabolic perspective; however, compliance to these current treatment pathways is poor.
Glucagon-like peptide receptor agonist (GLP1-RA) therapy is commonly used in the treatment of diabetes. This drug has been shown in a variety of large-scale, randomized-controlled trials to effectively improve obesity and insulin resistance. To date, there have been no studies to examine the effects of GLP1-RA on OSA in patients with T2DM. Therefore, our objective is to examine the efficacy of 26-weeks of GLP1-RA, with and without CPAP, in obese patients with OSA and T2DM. This study will yield clinically important data which have the potential to impact clinical practice for this high-risk population.
Following screening, patients with OSA and T2DM will be recruited from primary (GPs) and secondary care settings (out-patients clinics) across the Liverpool and Newcastle areas. After informed consent has been obtained patients will undergo a series of physiological assessments to examine metabolic and cardiovascular health and will then randomised to an intervention; i) control (no intervention, ii) GLP1-RA, iii) CPAP, iv) GLP1-RA & CPAP. All assessments will be repeated following the intervention period.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1019
Date of REC Opinion
4 Aug 2014
REC opinion
Further Information Favourable Opinion