The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Insulin resistance
研究概览
简要总结
This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed moderate-severe OSA (by standard PSG)
- •Body mass index between 30 - 40
- •Age 18 - 60 years
- •Able to provide written, informed consent
排除标准
- •Pregnancy
- •Requirement for supplemental oxygen
- •Previous diagnosis of OSA or previous CPAP treatment
- •Diagnosis of Diabetes
- •Previous treatment with GLP-1 analogue
- •Previous surgical treatment for obesity
- •Active treatment for malignancy or severe psychiatric disorder
- •Acute coronary syndrome or stroke within 3 months prior to study
- •History of decompensated heart failure
- •Professional drivers or drivers with a history of road-traffic accident due to sleepiness
- •Severe excessive daytime sleepiness defined as Epworth sleepiness scale >15
研究组 & 干预措施
Continuous positive airway pressure (CPAP)
Standard CPAP Therapy
干预措施: Continuous positive airway pressure treatment (Device)
Liraglutide-based weight loss regimen
Once daily s.c. injections of Liraglutide, starting at a dose of 0.6 mg with weekly 0.6 mg increments to 3.0 mg in adjunct to advice on a weight-reduction diet and physical exercise
干预措施: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml (Drug)
Combination CPAP/Liraglutide
Combination of both interventions
干预措施: Liraglutide and CPAP (Combination Product)
结局指标
主要结局
Insulin resistance
时间窗: 6 months
Improvement in insulin resistance defined by HOMA-IR
次要结局
- Weight(6 months)
- Glucose tolerance(6 months)
- Endothelial function(6 months)
- OSA Severity(6 months)
- Blood pressure(6 months)
- Coronary artery calcification(6 months)
- Vascular inflammation(6 months)
研究者
Dr Silke Ryan
Associate Professor, Consultant in Respiratory and Sleep Medicine
St Vincent's University Hospital, Ireland