Back to resultsPlasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome (URANOS)
Primary Purpose
Arginine Vasopressin Deficiency, Primary Polydipsia
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Urea
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Arginine Vasopressin Deficiency focused on measuring diabetes insipidus, copeptin, oral urea
Eligibility Criteria
Healthy volunteers Inclusion Criteria: Age ≥18 years Healthy with no medication except hormonal contraception Exclusion Criteria: Participation in a trial with investigational drugs within 30 days Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h Known allergy towards components of the study drink Pregnancy and breastfeeding Intention to become pregnant during the study Evidence of acute illness Patients Inclusion Criteria: 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 Exclusion Criteria: Participation in a trial with investigational drugs within 30 days Known allergy towards components of the study drink Pregnancy and breastfeeding Evidence of acute illness
Sites / Locations
- University Hospital BaselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Study Part 1 urea followed by placebo
Study Part 1 placebo followed by urea
Study part 2 Urea
Arm Description
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.
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.
Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea
Outcomes
Primary Outcome Measures
Difference in maximal increase in copeptin levels in plasma (pmol/l)
The difference in maximal increase in copeptin levels in plasma (pmol/l) within 150 minutes after oral intake of urea versus placebo, with the maximal increase being the difference between baseline copeptin values measured at the beginning of the test and maximal values measured between 30 and 150 minutes after ingestion.
Secondary Outcome Measures
Full Information
NCT ID
NCT05890690
First Posted
May 23, 2023
Last Updated
June 6, 2023
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT05890690
Brief Title
Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome
Acronym
URANOS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
This study consists of two parts, including healthy adults (study part 1 - proof of concept) and adults with an established diagnosis of PP or AVP-D (study part 2 - pilot study).
If the results of study part 1 suggest that oral urea is a potent stimulator of copeptin in healthy adults, study part 2 will be conducted, meaning that adults with an established diagnosis of PP or AVP-D will be included. If study part 1 demonstrates no relevant copeptin increase in response to oral urea, the study will be terminated thereafter and study part 2 will not be conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arginine Vasopressin Deficiency, Primary Polydipsia
Keywords
diabetes insipidus, copeptin, oral urea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
double-blind, randomized, placebo-controlled cross-over proof-of-concept and pilot study
Masking
ParticipantInvestigator
Masking Description
Study staff and participants are blinded upon the nature of each study visit. The preparation of the study medication or placebo will be performed by unblinded study staff who is otherwise not involved in the trial.
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Part 1 urea followed by placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Study Part 1 placebo followed by urea
Arm Type
Experimental
Arm Description
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.
Arm Title
Study part 2 Urea
Arm Type
Experimental
Arm Description
Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea
Intervention Type
Diagnostic Test
Intervention Name(s)
Urea
Intervention Description
Diagnostic test with a single weight-adapted dose of oral urea dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid).
The investigators will make use of the lemon-lime flavor to soften the bitter taste of urea.
- Dose calculation: 0.5 g urea/kg body weight (rounded to no decimal places), with a minimal dose of 30g and a maximal dose of 45g.
Intervention Type
Diagnostic Test
Intervention Name(s)
Placebo
Intervention Description
Diagnostic test with a single weight-adapted dose of placebo dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid).
The placebo will contain a mixture of bitter herbal substances to mimic the taste of urea.
- Dose calculation: 22 ml of placebo containing 20 ml Ergytonyl®, 1 ml Carmol®, and 1 ml Bitter Liebe®.
Primary Outcome Measure Information:
Title
Difference in maximal increase in copeptin levels in plasma (pmol/l)
Description
The difference in maximal increase in copeptin levels in plasma (pmol/l) within 150 minutes after oral intake of urea versus placebo, with the maximal increase being the difference between baseline copeptin values measured at the beginning of the test and maximal values measured between 30 and 150 minutes after ingestion.
Time Frame
up to 6 time assessment until 150 minutes after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy volunteers
Inclusion Criteria:
Age ≥18 years
Healthy with no medication except hormonal contraception
Exclusion Criteria:
Participation in a trial with investigational drugs within 30 days
Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h
Known allergy towards components of the study drink
Pregnancy and breastfeeding
Intention to become pregnant during the study
Evidence of acute illness
Patients
Inclusion Criteria:
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
Exclusion Criteria:
Participation in a trial with investigational drugs within 30 days
Known allergy towards components of the study drink
Pregnancy and breastfeeding
Evidence of acute illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirjam Christ-Crain, Prof.
Phone
+41 61 328 70 80
Email
mirjam.christ-crain@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Lustenberger
Phone
+41 61 328 62 64
Email
sven.lustenberger@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, Prof.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, Prof.
Phone
+41 61 328 70 80
Email
mirjam.christ-crain@usb.ch
First Name & Middle Initial & Last Name & Degree
Sven Lustenberger
Phone
+41 61 328 62 64
Email
sven.lustenberger@usb.ch
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, Prof.
First Name & Middle Initial & Last Name & Degree
Cihan Atila, Dr.
First Name & Middle Initial & Last Name & Degree
Sven Lustenberger
12. IPD Sharing Statement
Learn more about this trial
Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome
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