Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- catecholamines
研究概览
简要总结
The purpose of this study is to determine what corticosteroid receptor (and the dose of) is responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM. Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes hypoglycemia associated autonomic dysfunction in Type 1 DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •16 (8 males, 8 females) Type 1 diabetic patients aged 18-45 yr.
- •HbA1c > 7.0%
- •Had diabetes for 2-15 years
- •No clinical evidence of diabetic tissue complications
- •16 (8 males, 8 females) Healthy volunteers aged 18-45 yrs.
- •Body mass index < 27kg · m-2
排除标准
- •Prior or current history of poor health
- •Abnormal results following blood and physical examination
- •Pregnancy
研究组 & 干预措施
1
Day 1 hyperinsulinemic euglycemic clamps with either 0.2 mg fludrocortisone, 0.75 mg Dexamethasone, or both given orally before each morning and afternoon clamp. Day 2 hyperinsulinemic hypoglycemic glucose clamp.
干预措施: Fludrocortisone (Drug)
2
Fludrocortisone will be administered in doses of 0.05mg, 0.1mg and 0.2 mg form at the start of each clamp period on day 1. Dexamethasone will be administered orally in the doses of 0.18 mg, 0.375mg and 0.75mg doses. The combination of the 0.05mg fludrocortisone and 0.18mg dexamethasone and 0.1mg of fludrocortisone and 0.375 mg doses will be administered at the start of each day 1 clamp period. Day 2 90 minutes of moderate exercise.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
catecholamines
时间窗: 1 year
次要结局
未报告次要终点
研究者
Steve Davis
Department Chair
Vanderbilt University