Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome (URANOS)

University Hospital Basel

Status: Completed

Conditions: Arginine Vasopressin Deficiency; Primary Polydipsia

Treatments: Diagnostic Test: Placebo; Diagnostic Test: Urea

Study type: Interventional

Funder types: Other

Identifiers

NCT05890690

2023-00751 kt23christcrain2;

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 3 patient groups

Study Part 1 urea followed by placebo

Experimental group

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.

Treatment:

Diagnostic Test: Urea

Diagnostic Test: Placebo

Study Part 1 placebo followed by urea

Experimental group

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.

Treatment:

Diagnostic Test: Urea

Diagnostic Test: Placebo

Study part 2 Urea

Experimental group

Description:

Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea

Treatment:

Diagnostic Test: Urea