Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Palmitate oxidation in skeletal muscle
研究概览
简要总结
Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80% of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the development of glucose intolerance and T2DM. The project is targeting the gap in providing effective treatment of metabolic impairments associated with OSA, particularly T2DM. In contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure) on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP treatment, as investigators suggested recently. Clearly, the search for additional treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM development. The aim of the study is to target adipose tissue and muscle dysfunction leading to elevated FFA and develop thus novel pharmacological treatments based on lipolysis inhibition and stimulation of FFA oxidation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetes mellitus
- •Age 18 - 85 years
- •BMI 22-40 kg/m2
- •moderate or severe OSA diagnosed by home sleep study
排除标准
- •treatment with insulin
- •other acute or chronic endocrine or inflammatory disease
结局指标
主要结局
Palmitate oxidation in skeletal muscle
时间窗: Baseline and 6 months
Changes in palmitate oxidation in muscle biopsies measured ex vivo
Glycerol release (lipolysis) in adipose tissue
时间窗: Baseline and 6 months
Changes in interstitial glycerol concentration in adipose tissue
次要结局
未报告次要终点
研究者
Jan Polak
Associate Professor
Faculty Hospital Kralovske Vinohrady
