Copeptin After a Subcutaneous Stimulation With Glucagon in Adults (Healthy Volunteers and Patients With Diabetes Insipidus or Primary Polydipsia) - The Glucacop-Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Maximal increase in copeptin level
研究概览
简要总结
This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia). It is to investigate whether glucagon stimulates the release of copeptin as a surrogate of vasopressin.
详细描述
The differentiation between central diabetes insipidus (cDI) and primary polydipsia (PP) is cumbersome. To date the test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline Infusion.
Instead of hypertonic saline Infusion, arginine infusion - known to stimulate growth hormone - is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%. Glucagon has been shown to stimulate GH-secretion. In analogy to the known stimulatory effect of arginine Infusion it is hypothesized that glucagon might stimulate the posterior pituitary gland and could therefore be a novel diagnostic test in the polyuria-polydipsia syndrome.
This study is to evaluate copeptin values after the subcutaneous injection of glucagon in adults (healthy volunteers and patients with diabetes insipidus or primary polydipsia).
This study is planned as a double-blind randomized-controlled cross-over trial consisting of two parts, including healthy adults (study part 1 - proof of concept) and adults with known diagnosis of cDI or PP (study part 2 - pilot study). Study parts 1 and 2 will be conducted consecutively. If the results of study part 1 suggest that glucagon is a potent stimulator of Copeptin in healthy adults, study part 2 will be conducted. Participants will receive glucagon injection and placebo injection in random order.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for healthy volunteers:
- •no medication except hormonal contraception
- •Inclusion criteria for patients:
- •Documented primary polydipsia or diabetes insipidus based on a water deprivation test or hypertonic saline Infusion
- •Accordingly patients must have evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h, or must be on regular daily Desmopressin medication.
排除标准
- •for healthy volunteers:
- •BMI > 25kg/m2 or < 18.5 kg/m2
- •participation in a trial with investigational drugs within 30 days
- •vigorous physical exercise within 24 hours before the study participation
- •Alcohol intake within 24 hours before study participation
- •pregnancy and breastfeeding
- •Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg Body weight/24h and polydipsia >3l /24h
- •Intention to become pregnant during the study
- •Known allergy towards glucagon
- •Evidence of an acute illness
- •Long QT syndrome
- •Hemoglobin level below 120 g/l
- •Exclusion criteria for patients:
- •BMI > 25kg/m2 or < 18.5 kg/m2
- •participation in a trial with investigational drugs within 30 days
- •vigorous physical exercise within 24 hours before the study participation
- •Alcohol intake within 24 hours before study participation
- •pregnancy and breastfeeding
- •Evidence of an acute illness
- •Long QT syndrome
- •Hemoglobin level below 120 g/l
结局指标
主要结局
Maximal increase in copeptin level
时间窗: Within three hours after the injection
Maximal increase in copeptin level within three hours after the injection of a single subcutaneous dose of 1mg glucagon or 0.9% NaCl. That is the difference between the maximal copeptin value measured between 30 and 180 minutes after the injection and the baseline value. measured before the injection.
次要结局
- Change in copeptin values(Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection)
- Change in plasma sodium(Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection)
- Maximal Change in plasma osmolality(Within three hours after the injection)
- Maximal Change in oxytocin(Within three hours after the injection)
- Maximum copeptin time: the time from baseline to the maximum copeptin value(Within three hours after the injection)
- Change in growth hormone (GH)(Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection)
- Change in plasma osmolality(Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection)
- Change in prolactin(Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection)
- Change in oxytocin(Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection)
- Maximal Change in GH(Within three hours after the injection)
- Maximal Change in prolactin(Within three hours after the injection)