Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in level of catecholamines in blood from baseline
研究概览
简要总结
Elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar (hypoglycemia) appear to be responsible for the deficient responses during subsequent hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone (DHEA), a hormone with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in type 1 diabetic volunteers.
详细描述
DHEA is the acronym for dehydroepiandrosterone, a steroid hormone produced naturally from cholesterol in the adrenal glands of males and females. It is also sold as an over-the-counter dietary supplement, and seems to have anticorticosteroid effects. DHEA antagonizes the effects of corticosterone on hippocampal function in rats and reduces responses to neural stress in mice. In our lab we have found that administration of the DHEA to rats during antecedent hypoglycemia, preserves counter-regulatory responses to subsequent hypoglycemia. The purpose of this study is to determine if the same response occurs in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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) Healthy volunteers aged 18-45 yr.
- •28 (14 males, 14 females) Type 1 diabetic patients aged 18-45 yr.
- •HbA1c < 11.0%
- •Has been diagnosed Type 1 DM
- •No major diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
- •Body mass index < 40kg/m-2
排除标准
- •pregnancy
- •Medical history-
- •Hepatic Failure/Jaundice
- •Renal Failure
- •Acute Cerebrovascular/ Neurological deficit
- •Physical Exam-
- •Pneumonia
- •Fever greater than 38.0 C
- •Blood labs according to protocol
研究组 & 干预措施
1
Hyperinsulinemic (high dose insulin) hypoglycemic clamp studies with oral administration of DHEA or placebo prior to each clamp x 2 on day 1. Day 2 hyperinsulinemic hypoglycemia. Participant randomized to either DHEA or placebo for baseline trial (arm 1) and 6 weeks treatment.
干预措施: Dehydroepiandrosterone (Drug)
2
Following 6 weeks randomized treatment, Day 1 hyperinsulinemic hypoglycemic clamps x 2 with DHEA or placebo dose given prior to each clamp. Day 2 hypoglycemia with prior dose of randomized treatment.
干预措施: Dehydroepiandrosterone (Drug)
Arm 3 (optional)
Individuals will be asked to return after at least 2 months and repeat the trial they did not complete (for example, placebo if they were in the DHEA trial before). Again Day 1 would consist of two hyperinsulinemic clamps with placebo or DHEA given orally. Day 2 hyperinsulinemic hypoglycemic clamp with oral administration of placebo or DHEA.
干预措施: Placebo (Drug)
Arm 4
Following 6 weeks randomized treatment, Day 1 hyperinsulinemic hypoglycemic clamps x 2 with DHEA or placebo dose given prior to each clamp. Day 2 hypoglycemia with prior dose of randomized treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in level of catecholamines in blood from baseline
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Stephen N. Davis, MBBS
Professor
University of Maryland, Baltimore