Copeptin After a Subcutaneous Stimulation With Glucagon in Adults (Glucacop)
Diabetes Insipidus
About this trial
This is an interventional diagnostic trial for Diabetes Insipidus focused on measuring Copeptin, Glucagon, central diabetes insipidus, primary polydipsia, hypothalamo-pituitary-adrenal axis, posterior pituitary gland, polyuria-polydipsia syndrome
Eligibility Criteria
Inclusion Criteria 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.
Exclusion Criteria 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
Sites / Locations
- Divison of Endocrinology, Diabetes and Metabolism,University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
study part 1: healthy adult volunteers
study part 2: adult patients with primary polydipsia or central diabetes insipidus
22 Healthy volunteers: The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon).
If results of study part 1 suggest that glucagon stimulates copeptin (proof of concept),10 patients with primary polydipsia and 10 patients with central diabetes insipidus will be additionally included (study part 2): The half of the study group will start with test day A (injection of glucagon), followed by test day B (injection of placebo) and the other half will start with test day B (injection of placebo), followed by test day A (injection of glucagon).