跳至主要内容
临床试验/NCT02683616
NCT02683616已完成不适用

Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Faculty Hospital Kralovske Vinohrady2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年4月1日最近更新:
适应症

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

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

发起方
Faculty Hospital Kralovske Vinohrady
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jan Polak

Associate Professor

Faculty Hospital Kralovske Vinohrady

研究点 (2)

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