The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Glucagon (pg/mL)
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). The aim of this study is to determine whether a formoterol inhaler can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.
详细描述
Note: Below is the original detailed description submitted in 2010. The recruitment for this study was stopped at 7 subjects in each study arm. The study design and outcome measures did not change for this study. See below for further details.
Original: 15 subjects with well controlled type 1 diabetes and regular hypoglycemia and 15 healthy volunteers will be recruited for this study.
If you agree to participate in this study, you will be asked to participate in a screening at Yale New Haven Hospital. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, the subject will be given an inhaler. On one visit the inhaler will contain formoterol capsules and on the other visit, the subject will be given 'dummy' capsules. Subjects will be required to be admitted to the HRU the night before the study so that glucose levels can be stabilized and hypoglycemia avoided.
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 18-50
- •BMI 18-30
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
Type 1 Diabetics
The active group were participants with type 1 diabetes.
干预措施: Formoterol (Drug)
Type 1 Diabetics
The active group were participants with type 1 diabetes.
干预措施: Placebo (Other)
Healthy Volunteers
The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.
干预措施: Formoterol (Drug)
Healthy Volunteers
The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.
干预措施: Placebo (Other)
结局指标
主要结局
Glucagon (pg/mL)
时间窗: up to 120 minutes
Glucagon levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages.
Epinephrine (pg/mL)
时间窗: up to 120 minutes
Epinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages
Norepinephrine (pg/mL)
时间窗: up to 120 minutes
Norepinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages
次要结局
- Blood Glucose Levels (Average)(Up to 120 minutes)