Article ; Online: 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).
2020 Volume 10, Issue 7, Page(s) e038856
Abstract: Introduction: 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 ( ... ...
| Abstract | Introduction: 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. Methods and analysis: 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 (HbA Ethical approval: The study has been approved by the North West Liverpool Central Research Ethics Committee (14/NW/1019) and it is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Trial registration numbers: ISRCTN16250774. EUDRACT No. 2014-000988-41. UTN U1111-1139-0677. |
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| MeSH term(s) | Continuous Positive Airway Pressure ; Cross-Sectional Studies ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Glucagon-Like Peptide-1 Receptor ; Humans ; Liraglutide/therapeutic use ; Multicenter Studies as Topic ; Prospective Studies ; Quality of Life ; Randomized Controlled Trials as Topic ; Sleep Apnea, Obstructive/complications ; Sleep Apnea, Obstructive/therapy ; Treatment Outcome ; Weight Loss |
| Chemical Substances | Glucagon-Like Peptide-1 Receptor ; Liraglutide (839I73S42A) |
| Language | English |
| Publishing date | 2020-07-22 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2599832-8 |
| ISSN | 2044-6055 ; 2044-6055 |
| ISSN (online) | 2044-6055 |
| ISSN | 2044-6055 |
| DOI | 10.1136/bmjopen-2020-038856 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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