Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- catecholamine levels
研究概览
简要总结
Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.
详细描述
When a person had previously experienced bouts of low blood sugar, or hypoglycemia, his or her counterregulatory responses to hypoglycemia would be weakened. This is especially true and important for a person with Type 1 diabetes, because it will cause him or her to be vulnerable to another bout of hypoglycemia, and cause hypoglycemia unawareness, which can lead to serious or even life-threatening consequences. Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C > 8.5%
- •28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C < 7%
- •28 (14 males, 14 females) non-diabetic controls
- •Age 18-45 yr.
- •Had diabetes for 2-15 years if diabetic subject
- •No clinical evidence of diabetic tissue complications, no cardiovascular disease
- •Body mass index 21-27kg · m-2
- •Normal bedside autonomic function
- •Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
- •Female volunteers of childbearing potential: negative HCG pregnancy test
排除标准
- •Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
- •Hemoglobin of less than 12 g/dl
- •Abnormal results following screening tests
- •Pregnancy
- •Subjects unable to give voluntary informed consent
- •Subjects with a recent medical illness
- •Subjects with known liver or kidney disease
- •Subjects taking steroids
- •Subjects taking beta blockers
- •Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
研究组 & 干预措施
1
Hyperinsulinemic euglycemic glucose clamp study on day 1 Hyperinsulinemic euglycemic clamp study on day 2 with epinephrine infusion
干预措施: epinephrine (Drug)
2
Hyperinsulinemic hypoglycemic glucose clamp x 2 on day 1 Hyperinsulinemic euglycemic clamp with epinephrine infusion on Day 2
干预措施: epinephrine (Drug)
结局指标
主要结局
catecholamine levels
时间窗: 2 days
次要结局
未报告次要终点
研究者
Steve Davis
Chairman of Medicine, University of Maryland, Baltimore
Vanderbilt University