Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome: a Double-blind, Randomized, Placebo-controlled Cross-over Proof-of-concept and Pilot Study - The URANOS Study
Status: Completed
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Age ≥18 years
• Healthy with no medication except hormonal contraception
• Age ≥ 18 years
• Documented PP or AVP-D based on accepted diagnostic criteria, i.e., water deprivation test, hypertonic saline infusion test or arginine infusion test. Accordingly, patients must have evidence of disordered drinking habits and diuresis defined as polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h or must be on regular daily desmopressin medication
Locations
Other Locations
Switzerland
University Hospital Basel
Basel
Time Frame
Start Date: 2023-06-02
Completion Date: 2024-06-24
Participants
Target number of participants: 48
Treatments
Experimental: Study Part 1 urea followed by placebo
Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of placebo.
Experimental: Study Part 1 placebo followed by urea
Participants will undergo a diagnostic test with a single weight-adapted dose of placebo first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of urea.
Experimental: Study part 2 Urea
Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland