Clinical trial NCT03844217: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers
Official title: Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers - The Macicop-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyuria-polydipsia Syndrome
Keywords: Copeptin
Macimorelin
Ghrelin receptor agonist
posterior pituitary gland
polyuria-polydipsia syndrome
hypothalamo-pituitary-adrenal axis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Intervention model description: Prospective, proof-of concept diagnostic study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.5mg/kg body weight
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Secondary outcomes:
measure: Change in Copeptin value (pmol/l), after intake of Macimorelin of 0.75mg/kg body weight
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Growth Hormone (GH) value (ng/mL)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Insulin-like growth factor 1 (IGF-1) value (yg/mL)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in free thyroxine (fT4) value (ng/dL)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Thyreotropin (TSH) value (mU/L)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Prolactin value (yg/L)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Cortisol value (ng/mL)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Adrenocorticotropin (ACTH) value ( pg/mL)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Luteotropin (LH) value (U/L)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
measure: Change in Follicle-stimulating hormone value(FSH) (IU/mL)
timeFrame: baseline blood exam (timepoint 0) and further blood collections after 30, 45, 60, 90 and 120 minutes after baseline blood collection
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel Endocrinology, Diabetes and Metabolism
Study officials:
affiliation: Endocrinology, Diabetes and Metabolism, University Hospital Basel
name: Mirjam Christ-Crain, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.