The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cerebral Activation During Hypoglycaemia
研究概览
简要总结
The purpose of this study is to evaluate the cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone system which is involved in the regulation of the blood pressure. Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively
详细描述
The purpose of this study is to evaluate the regional cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS). Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male Age 18-40 years Right-handed In good general health based on history High/low RAS activity (high ACE activity, A-allele for angiotensin II receptor (subtype 2) and high plasma angiotensinogen, or low ACE activity, low plasma angiotensinogen and not carrier of the A-allele for angiotensin II receptor (subtype 2)).
排除标准
- •Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year
研究组 & 干预措施
High RAS activity
10 healthy men were characterized by having high basal RAS activity.
干预措施: Human insulin (Drug)
Low RAS activity
10 healthy men were characterized by having either a low basal RAS activity.
干预措施: Human insulin (Drug)
结局指标
主要结局
Cerebral Activation During Hypoglycaemia
时间窗: After 4 scans on day 1
To compare the high RAS activity vs low RAS activity a Z score was used.
次要结局
未报告次要终点
研究者
Birger Thorsteinsson
Professor
Hypoglycaemia Research Group