Recurrent Hypoglycaemia in Type 1 Diabetes: Effects on Cognitive Function, Cerebral Electrical Activity, and Skin Temperature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- EEG
研究概览
简要总结
Patients with type 1 diabetes are at risk of very low blood sugar levels (hypoglycaemia) as a severe side effect to insulin therapy, in particular subjects who have lost warning of hypoglycaemia. During hypoglycaemia a low frequent activity can be seen with electroencephalography (EEG) as cognitive function declines.
The purpose of the study is to investigate the activity in the brain, the cognitive function, and the skin temperature when patients are exposed to repeated hypoglycaemia. The results will show whether the response to hypoglycaemia will change after repeated episodes.
It is our hope that results can contribute to improved understanding of hypoglycaemic EEG changes.
详细描述
Background:
Patients with type 1 diabetes are at risk of severe hypoglycaemia as a severe side effect to insulin therapy, in particular subjects who have lost warning of hypoglycaemia (hypoglycaemia unawareness). The episodes are associated with impaired quality of life and can lead to permanent brain damage and death.
During hypoglycaemia a low frequent activity can be seen with electroencephalography (EEG) as cognitive function declines. Repeated hypoglycaemic episodes result in down regulation of counter regulatory and symptomatic responses. It is not known whether a similar phenomenon is present for cerebral dysfunction as judged by EEG changes and cognitive function.
The purpose is to investigate the activity in the brain, the cognitive function, and the skin temperature when patients are exposed to repeated hypoglycaemia. The results will show whether the response to hypoglycaemia will change after repeated episodes.
The methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Age > 18 years
- •- Have had diabetes for more than 5 years
- •Negative pregnancy test
- •Caucasian
- •Signed written informed consent
排除标准
- •Pregnant or breastfeeding
- •Self-perceived impaired hearing
- •Use of antiepileptic medicine
- •Use of neuroleptics within the last 6 months
- •Use of benzodiazepines within the last month
- •Use of betablockers
- •Previous stroke or other disease in the brain
- •Cardiovascular disease
- •Alcohol-, drug- or medicine abuse
- •Previous allergic reaction to heparin
结局指标
主要结局
EEG
时间窗: 2 years
EEG will be analysed in order to see whether there are any differences between aware and unaware patients during hypoglycaemia. It is our hope that the result can help develop an alarm before the patient experiences severe hypoglycaemia.
次要结局
- QTc interval(2 years)
- Skin temperature(2 years)
- Auditory evoked potentials(2 years)
- Cognitive function(2 years)
研究者
Anne-Sophie Sejling
MD
Hillerod Hospital, Denmark