Influence of Blockade of the Renin-angiotensin System for Preservation of Cognitive Function, Hormonal Counter-regulatory Response, Symptomatology and Cardiac Repolarisation During Hypoglycaemia in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Cognitive function and brain cortical activity assessed by EEG
研究概览
简要总结
Hypothesis: Treating patients with type 1 diabetes with a certain antihypertensive drug preserve cerebral function during hypoglycaemia.
Background: Studies have found that certain genetic variations leaves a subject with type 1 diabetes more prone to hypoglycaemia. It it thought to be a decline in cognition during hypoglycaemia that leaves them at risk of severe hypoglycaemia. The idea is tha when you suppress the genetic phenotype with a well known antihypertensive drug an improvement in cognition will occur and this will remove the patients tendency to severe hypoglycaemia.
Methods: The investigators want to explore whether the cerebral function is improved during hypoglycaemia in subjects with type 1 diabetes and the above mentioned genetic variation when treated with the antihypertensive drug Candesartan.
详细描述
We will include 25 type 1 diabetic patients from our outpatient clinic. They are already genotyped from another trial.
Each patient goes through two cycles with hyperinsulinemic glucose clamp induced hypoglycemia. The study is double blinded, randomised and placebocontrolled so the patients receive both Candesartan and placebo but in different cycles.
In each cycle patients will receive either Candesartan or placebo for 7 days. After 8 days patients undergo a hypoglycaemic clamp during which primary and secondary endpoints will be measured.
In the hyperinsulinemic hypoglycaemic clamp the patients will undergo an adjustment period towards euglycaemia. A period of approximately 1 hour of euglycemia, an hour of hypoglycemia and a period of recovery towards euglycemia. In each of these glycemic states primary and secondary outcomes will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Danish spoken and written
- •RAS activity score>7 - diabetes duration > 5 years
- •not pregnant and safe anticonception
- •Signed informed consent.
排除标准
- •Treatment with an ACE blocker
- •An ARB og a renin blocker
- •Treatment with other antihypertensive drugs
- •Severe diabetic late complications
- •Renal impairment
- •Pregnancy and breastfeeding
- •Previous reactions to study medication
- •Heart insufficiency (NYHA 3-4)\
- •Known ischaemic heart disease
- •Alcohol and drug abuse
- •Suspicion of non-compliance,
- •Plasma potassium < 3.5 mmol/l or >5.0 mmol/l.
研究组 & 干预措施
Candesartan
干预措施: Angiotensin II receptor antagonists (Candesartan) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cognitive function and brain cortical activity assessed by EEG
时间窗: 2 month
次要结局
- Symptoms of hypoglycaemia assessed by Edinburgh Hypoglycaemia Symptom Score questionnaire(2 month)
- Hormonal counter-regulatory response and substrates(2 month)
- Blood pressure and pulse(2 month)
- Cardiac conduction evaluated by a three channel digital Holter Monitor.(2 month)
研究者
Louise Faerch
MD, ph.d.student
Hillerod Hospital, Denmark