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ROMANCE

A randomised, 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)

ROMANCE

A randomised, 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)
Funding Novo Nordisk
Portfolio Clinical Specialties
Interventions Medicine
Randomised Yes
Status In Follow-up
Start Date 10-Sep-2015

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 longterm
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.
Glucagonlike
peptide receptor agonist (GLP1RA)
therapy is commonly used in the treatment of diabetes. This drug
has been shown in a variety of largescale,
randomizedcontrolled
trials to effectively improve obesity and insulin
resistance. To date, there have been no studies to examine the effects of GLP1RA
on OSA in patients with T2DM.
Therefore, our objective is to examine the efficacy of 26weeks
of GLP1RA,
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 highrisk
population.
Following screening, patients with OSA and T2DM will be recruited from primary (GPs) and secondary care settings
(outpatients
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) GLP1RA,
iii) CPAP, iv) GLP1RA
& CPAP. All assessments
will be repeated following the intervention period.

Publications

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