Copeptin After a Subcutaneous Stimulation With Glucagon in Adults
- Conditions
- Diabetes Insipidus
- Interventions
- Diagnostic Test: GlucagonDiagnostic Test: Placebo
- Registration Number
- NCT04550520
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description study part 1: healthy adult volunteers Glucagon 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). study part 2: adult patients with primary polydipsia or central diabetes insipidus 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). study part 2: adult patients with primary polydipsia or central diabetes insipidus Placebo 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). study part 1: healthy adult volunteers Placebo 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).
- Primary Outcome Measures
Name Time Method Maximal increase in copeptin level 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.
- Secondary Outcome Measures
Name Time Method Change in copeptin values Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection Change in copeptin values
Change in plasma sodium Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection Change in plasma sodium
Maximal Change in plasma osmolality Within three hours after the injection Maximal Change in plasma osmolality
Maximal Change in oxytocin Within three hours after the injection Maximal Change in oxytocin
Maximum copeptin time: the time from baseline to the maximum copeptin value Within three hours after the injection Maximum copeptin time: the time from baseline to the maximum copeptin value
Change in growth hormone (GH) Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection Change in growth hormone (GH)
Change in plasma osmolality Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection Change in plasma osmolality
Change in prolactin Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection Change in prolactin
Change in oxytocin Measured at 0 (baseline), 30, 60, 90, 120, 150 and 180 minutes after injection Change in oxytocin
Maximal Change in GH Within three hours after the injection Maximal Change in GH
Maximal Change in prolactin Within three hours after the injection Maximal Change in prolactin
Trial Locations
- Locations (1)
Divison of Endocrinology, Diabetes and Metabolism,University Hospital Basel
🇨ðŸ‡Basel, Switzerland