Status:
COMPLETED
Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Polyuria-polydipsia Syndrome
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- No medication except hormonal contraception
Exclusion
- 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
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03844217
Start Date
March 7 2019
End Date
July 16 2019
Last Update
August 8 2019
Active Locations (1)
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1
University Hospital Basel Endocrinology, Diabetes and Metabolism
Basel, Switzerland, 4031