The Effect of Lixisenatide on the Effect of Pituitary Hormones
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Growth hormone area under the curve.
研究概览
简要总结
The current study has two aims:
- to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test;
- to test if the growth hormone-stimulating effect is mediated by changes in blood glucose.
The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).
详细描述
The randomized, blinded, placebo-controlled clinical trial is conducted on 5 healthy volunteers and 5 patients with type 1 diabetes.
All study subjects receive once a placebo and once 10 micrograms of lixisenatide.
The order of administration of study medication is decided on randomization. The placebo and lixisenatide are administered at least 2 days apart.
Blood samples are taken 30 minutes and immediately before study medication administration and 30, 60, 90, 120, and 150 minutes after study medication administration,.
The primary endpoint is the peak value of growth hormone measured during the 2,5 hours after study medication administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •age 18-60 years
- •body weight > 65 kg
- •Patients with type 1 diabetes:
- •type 1 diabetes
- •age 18-60 years
- •body weight > 65 kg
- •c-peptide in fasting blood sample <0,1 nmol/l
- •HbA1c < 8,5%
排除标准
- •Healthy volunteers:
- •use of aldosterone antagonist
- •use of glucocorticosteroid
- •use of other medication that potentially significantly affects pituitary function.
- •Patients with type 1 diabetes:
- •use of aldosterone antagonist
- •use of glucocorticosteroid
- •use of other medication that potentially significantly affects pituitary function.
- •The patient is excluded from the study if a significant change in blood glucose occurs in the study center.
研究组 & 干预措施
Placebo, type 1 diabetic patients
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
干预措施: Placebo (Drug)
Placebo, healthy volunteers
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
干预措施: Placebo (Drug)
Lixisenatide 10 micrograms, healthy volunteers
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
干预措施: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector (Drug)
Lixisenatide 10 micrograms, type 1 diabetic patients
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
干预措施: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector (Drug)
结局指标
主要结局
Growth hormone area under the curve.
时间窗: 0-150 minutes after study drug administration
Treatment effect (placebo vs lixisenatide) on growth hormone area under curve (AUC) is compared between patients with type 1 diabetes and healthy volunteers.
次要结局
- Aldosterone peak(30, 60, 90, 120, and 150 minutes after the study drug administration)
- Cortisol peak(30, 60, 90, 120, and 150 minutes after the study drug administration)
- Prolactin peak(30, 60, 90, 120, and 150 minutes after the study drug administration)
- Growth hormone peak(30, 60, 90, 120, and 150 minutes after the study drug administration.)
- Glucose nadir(30, 60, 90, 120, and 150 minutes after the study drug administration)
- C-peptide peak(30, 60, 90, 120, and 150 minutes after the study drug administration)
- Copeptin peak(30, 60, 90, 120, and 150 minutes after the study drug administration)
- Adrenocorticotropic hormone (ACTH) peak(30, 60, 90, 120, and 150 minutes after the study drug administration)
研究者
Vallo Volke
professor
University of Tartu