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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macimorelin 0.5mg/kg body weight | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macimorelin 0.5mg/kg body weight | Drug | oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight | evaluate copeptin values after the intake of of a single oral-dose 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight | evaluate copeptin values after the intake of of a single oral-dose 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirjam Christ-Crain, Prof. Dr. MD | Endocrinology, Diabetes and Metabolism, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel Endocrinology, Diabetes and Metabolism | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33615399 | Derived | Urwyler SA, Lustenberger S, Drummond JR, Soares BS, Vogt DR, Ammer N, Yuen KCJ, Ribeiro-Oliveira A, Christ-Crain M. Effects of oral macimorelin on copeptin and anterior pituitary hormones in healthy volunteers. Pituitary. 2021 Aug;24(4):555-563. doi: 10.1007/s11102-021-01132-9. Epub 2021 Feb 22. |
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| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C582727 | macimorelin |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Prospective, proof-of concept diagnostic study
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| Macimorelin 0.75mg/kg body weight | Drug | oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin |
|
| Change in Growth Hormone (GH) value (ng/mL) |
evaluate GH values after the intake of of a single oral-dose Macimorelin |
| baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL) | evaluate IGF-1 values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in free thyroxine (fT4) value (ng/dL) | evaluate fT4 values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in Thyreotropin (TSH) value (mU/L) | evaluate TSH values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in Prolactin value (yg/L) | evaluate Prolactin values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in Cortisol value (ng/mL) | evaluate Cortisol values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in Adrenocorticotropin (ACTH) value ( pg/mL) | evaluate ACTH values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in Luteotropin (LH) value (U/L) | evaluate LH values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in Follicle-stimulating hormone value(FSH) (IU/mL) | evaluate FSH values after the intake of of a single oral-dose Macimorelin | baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |