NCT01789593已完成1 期
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 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
- 29
- 试验地点
- 1
- 主要终点
- Digit Symbol Substitution Test (DSST) score
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 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
- •Right-handed subjects
- •Type 1 diabetes mellitus for at least 12 months
- •Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
- •Body mass index 18.0-28.0 kg/m^2 (both inclusive)
排除标准
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening)
- •Visual impairment or auditory impairment
研究组 & 干预措施
Hypoglycaemia / euglycaemia clamp
Other
干预措施: glucose clamp (Other)
Euglycaemia clamp / hypoglycaemia
Other
干预措施: glucose clamp (Other)
结局指标
主要结局
Digit Symbol Substitution Test (DSST) score
时间窗: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
次要结局
- Paced Auditory Serial Addition Task (PASAT) score(During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored)
- Regional cerebral blood flow (rCBF) score(Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia)
研究者
研究点 (1)
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