A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Insulin sensitivity
研究概览
简要总结
This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia
详细描述
Iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management of diabetes. It causes recurrent morbidity in most people with type 1 diabetes and in many patients with type 2 diabetes and can be fatal. Episodes of hypoglycemia impair physiologically protective mechanism in subsequent episodes of hypoglycemia. This phenomenon is known as hypoglycemia-associated autonomic failure (HAAF), the clinical syndromes of defective glucose counter regulation and hypoglycemia unawareness.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •More than 5 years of disease duration
- •HbA1c 42-86 mmol/L
- •No known HAAF
- •BMI 22-28
- •Written consent
排除标准
- •Other disease than diabetes f.x epilepsy, ischemic heart disease or heart rhythm disturbance
- •Medication f.x beta-blockade, steroids, psychotropics
- •Drug abuse
- •Control subjects
- •Inclusion Criteria:
- •BMI 22-28
- •Written consent
- •Exclusion Criteria:
- •Diseases f.x diabetes, epilepsy, ischemic heart disease or heart rhythm disturbance
- •Medication f.x beta-blockade, steroids, psychotropics
- •Drug abuse
结局指标
主要结局
Insulin sensitivity
时间窗: Day 2 and day 4 (T=60 minutes - T=240 minutes)
Insulin sensitivity before, during hypoglycemia and after recovery from hypoglycemia on day 2 (one episode of hypoglycemia) compared with day 4 (two consecutive episodes of hypoglycemia). Insulin sensitivity is measured as M-value derived from the Glucose Infusion Rate (GIR) during a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp
次要结局
- Symptoms during hypoglycemia(Day 2 and day 4 (T=0 minutes - T=420 minutes))
- Hormonal counter regulatory response to hypoglycemia(Day 2 and day 4 (T=0 minutes, T=30, T=40, T=50, T=120, T=130, T=140, T160, T=170, T=180, T=210, T=220, T=230, T=390, T=400 and T=410)