Randomised, cOntrolled Multicentre trial of 26 weeks subcutaneous liraglutide (a glucagon-like peptide-1 receptor Agonist), with or without contiNuous positive airway pressure (CPAP), in patients with type 2 diabetes mellitus (T2DM) and obstructive sleep apnoEa (OSA) (ROMANCE): study protocol assessing the effects of weight loss on the apnea-hypnoea index (AHI)

BMJ Open
Victoria S SprungDaniel J Cuthbertson

Abstract

Obstructive sleep apnoea (OSA) and type 2 diabetes mellitus (T2DM) often occur concurrently, and untreated OSA may potentially amplify the high risk of cardiovascular disease in T2DM. Compliance with continuous positive airway pressure (CPAP), the conventional treatment for OSA, can be poor and considering weight loss is the most effective treatment for OSA. This trial examines whether the glucagon-like peptide-1 receptor agonist liraglutide, a glucose-lowering therapy associated with significant weight loss used in T2DM, can improve the severity and symptoms of OSA. This is an outpatient, single-centred, open-labelled, prospective, phase IV randomised controlled trial in a two-by-two factorial design. One hundred and thirty-two patients with newly diagnosed OSA (apnoea-hypopnoea index (AHI) ≥15 events/hour), and existing obesity and T2DM (glycated haemoglobin (HbA1c) ≥47 mmol/mol), will be recruited from diabetes and sleep medicine outpatient clinics in primary and secondary care settings across Liverpool. Patients will be allocated equally, using computer-generated random, permuted blocks of unequal sizes, to each of the four treatment arms for 26 weeks: (i) liraglutide (1.8 mg once per day) alone, (ii) liraglutide 1.8 mg onc...Continue Reading

References

Apr 29, 1993·The New England Journal of Medicine·T YoungS Badr
Jun 1, 1997·Journal of Sleep Research·L S BennettR J Davies
Feb 20, 2004·Respiratory Medicine·J R StradlingD M Smith
May 4, 2004·European Heart Journal·Steven R CoughlinJohn P H Wilding
Nov 12, 2005·The New England Journal of Medicine·H Klar YaggiVahid Mohsenin
Jan 27, 2006·The Cochrane Database of Systematic Reviews·T L GilesC J Cates
Mar 13, 2009·Diabetes Care·Gary D FosterUNKNOWN Sleep AHEAD Research Group
Sep 30, 2009·Archives of Internal Medicine·Gary D FosterUNKNOWN Sleep AHEAD Research Group of Look AHEAD Research Group
Oct 19, 2010·American Journal of Physiology. Heart and Circulatory Physiology·Dick H J ThijssenDaniel J Green
Jul 5, 2011·The Journal of Pediatrics·Louise H NaylorElizabeth A Davis
Jun 23, 2012·American Journal of Respiratory and Critical Care Medicine·Abd A TahraniMartin J Stevens
Jun 12, 2014·The New England Journal of Medicine·Julio A ChirinosAllan I Pack
Jul 3, 2015·The New England Journal of Medicine·Xavier Pi-SunyerUNKNOWN SCALE Obesity and Prediabetes NN8022-1839 Study Group
Aug 15, 2015·International Journal of Obesity : Journal of the International Association for the Study of Obesity·R DobsonD J Cuthbertson
Mar 24, 2016·International Journal of Obesity : Journal of the International Association for the Study of Obesity·A BlackmanE Mignot
Jun 14, 2016·The New England Journal of Medicine·Steven P MarsoUNKNOWN LEADER Trial Investigators
Apr 11, 2017·Obesity Science & Practice·A MehtaI J Neeland

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BETA
pharmacotherapy
pregnancy test

Software Mentioned

SenseWear Professional
Echopac
Airview
Nutritics ( Nutrition Analysis
Camtasia
Stata

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