Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers
- Conditions
- Polyuria-polydipsia Syndrome
- Interventions
- Registration Number
- NCT03844217
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- No medication except hormonal contraception
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Macimorelin 0.5mg/kg body weight Macimorelin 0.5mg/kg body weight Visit 1: oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin. Visit 2: After a washout-phase of 1 week, participants will undergo the oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight. Study procedures are equal compared to visit 1. Macimorelin 0.75mg/kg body weight Macimorelin 0.5mg/kg body weight Macimorelin 0.75mg/kg body weight Visit 1: oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin. Visit 2: After a washout-phase of 1 week, participants will undergo the oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight. Study procedures are equal compared to visit 1. Macimorelin 0.75mg/kg body weight
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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
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 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 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 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
Trial Locations
- Locations (1)
University Hospital Basel Endocrinology, Diabetes and Metabolism
🇨ðŸ‡Basel, Switzerland