Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Catecholamine levels
研究概览
简要总结
Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.
详细描述
Due to the fundamental importance of glucose as a cerebral fuel, a complex and redundant counterregulatory response to hypoglycemia exists in man. Some studies have shown that prior activation of GABA(A) receptors may result in blunting of counterregulatory responses during next day hypoglycemia.
The Specific Aim is to determine if repeated activation of GABA(A) receptors using Alprazolam will result in blunting of neuroendocrine, ANS and metabolic counterregulatory mechanisms during next day hypoglycemia in T1DM and healthy man.
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
- •16 (8 males, 8 females) Type 1 diabetes patients aged 18-45 yr.
- •16 (8 males, 8 females) healthy controls aged 18-45 yr.
- •HbA1c > 7.0% (Type 1 diabetes patients)
- •Had diabetes for 2-15 years (Type 1 diabetes patients)
- •No clinical evidence of diabetic tissue complications (Type 1 diabetes patients)
- •Body mass index 21-30 kg · 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 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
2
Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.
干预措施: Alprazolam (Drug)
1
Hyperinsulinemic glucose clamp in group with no drug.
干预措施: control group (Other)
结局指标
主要结局
Catecholamine levels
时间窗: Comparative study performed every 6-8 weeks
次要结局
未报告次要终点
研究者
Steve Davis
Department Chair
Vanderbilt University