Polyuria-polydipsia Syndrome
Conditions
Keywords
Copeptin, Macimorelin, Ghrelin receptor agonist, posterior pituitary gland, polyuria-polydipsia syndrome, hypothalamo-pituitary-adrenal axis
Brief summary
This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
Detailed description
Copeptin measurements upon intravenous arginine stimulation discriminate patients with diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy. An oral test would be easier to perform, causes less risks and discomfort for the patients and would require less resources in clinical practice. This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
Interventions
DRUGMacimorelin 0.5mg/kg body weight
oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin
DRUGMacimorelin 0.75mg/kg body weight
oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin
Sponsors
University Hospital, Basel, Switzerland
Study design
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, proof-of concept diagnostic study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* No medication except hormonal contraception
Exclusion criteria
* Body Mass Index (BMI) \> 40kg/m2 or BMI \< 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 * a prolonged QT interval (QTc \>500 ms) or concomitant treatment with drugs that prolong the QT/QTc. * Intention to become pregnant during the course of the study * Known allergy towards Macimorelin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate copeptin values after the intake of of a single oral-dose Macimorelin of 0.5mg/kg body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Growth Hormone (GH) value (ng/mL) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate GH values after the intake of of a single oral-dose Macimorelin |
| Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate IGF-1 values after the intake of of a single oral-dose Macimorelin |
| Change in free thyroxine (fT4) value (ng/dL) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate fT4 values after the intake of of a single oral-dose Macimorelin |
| Change in Thyreotropin (TSH) value (mU/L) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate TSH values after the intake of of a single oral-dose Macimorelin |
| Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate copeptin values after the intake of of a single oral-dose Macimorelin of 0.75mg/kg body weight |
| Change in Cortisol value (ng/mL) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate Cortisol values after the intake of of a single oral-dose Macimorelin |
| Change in Adrenocorticotropin (ACTH) value ( pg/mL) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate ACTH values after the intake of of a single oral-dose Macimorelin |
| Change in Luteotropin (LH) value (U/L) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate LH values after the intake of of a single oral-dose Macimorelin |
| Change in Follicle-stimulating hormone value(FSH) (IU/mL) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate FSH values after the intake of of a single oral-dose Macimorelin |
| Change in Prolactin value (yg/L) | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection | evaluate Prolactin values after the intake of of a single oral-dose Macimorelin |
Countries
Switzerland
Outcome results
None listed