The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Glucose (mg/dL)
研究概览
简要总结
Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, BMI 18-35
排除标准
- •pregnancy
- •significant diabetes complications
- •liver disease, cirrhosis
- •cardiac disease
- •neurological disorder
- •autonomic neuropathy
- •kidney disease
- •lactose intolerance
研究组 & 干预措施
Naltrexone (higher dose)
Naltrexone 100mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the high dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm.
干预措施: Naltrexone High Dose (Drug)
Naltrexone (lower dose)
Naltrexone 50mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the low dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm.
干预措施: Naltrexone Low Dose (Drug)
结局指标
主要结局
Glucose (mg/dL)
时间窗: End of study (up to 240 minutes)
Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Glucose Infusion Rate (mg/kg.Min)
时间窗: End of study (up to 240 minutes)
The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).
次要结局
- Cortisol (ug/dL)(End of study (up to 240 minutes))
- Epinephrine (pg/mL)(End of study (up to 240 minutes))
- Norepinephrine (pg/mL)(End of study (up to 240 minutes))
- Glucagon (pg/mL)(End of study (up to 240 minutes))