NCT01780272已完成1 期
A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The number of electroencephalogram (EEG) identified arousals
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the impact of low blood sugar during the night on sleep in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
- •Currently treated with any anti-diabetic treatment (incl. diet and exercise) except insulin with a stable dose for more than 4 weeks prior to screening
- •Body mass index below 35 kg/m^2
排除标准
- •Severe hypoglycaemic event during the past 6 months or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Any other chronic disorder or severe disease by clinical information (including chronic obstructive pulmonary disease (COPD), sleep apnoea and epilepsy) which, in the opinion of the investigator might jeopardise subject's sleep, safety or compliance with the protocol, or subjects with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator, should not participate in the trial
- •Use of antidepressants, antipsychotics, hypnotics, sedatives or other drugs known to influence sleep within 12 weeks prior to screening
研究组 & 干预措施
Normoglycaemia followed by hypoglycaemia
Other
干预措施: glucose clamp (Other)
Hypoglycaemia followed by normoglycaemia
Other
干预措施: glucose clamp (Other)
结局指标
主要结局
The number of electroencephalogram (EEG) identified arousals
时间窗: During the first four hours (0-4 hours) after reaching sleep stage N2
次要结局
- Total sleep time(0-8 hours)
- Time spent in the different sleep stages (% of total sleep time): Sleep stage N1, Sleep stage N2, Sleep stage N3 and Rapid Eye Movement (REM) sleep(During the first four hours (0-4 hours) after reaching sleep stage N2)
研究者
研究点 (1)
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