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

NCT05890690 | Completed

• 1 other identifier: 2023-00751; kt23christcrain2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Arginine Vasopressin Deficiency; Primary Polydipsia

Keywords

diabetes insipidus; copeptin; oral urea

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 time assessment until 150 minutes after baseline

Study Arms (3)

Study Part 1 urea followed by placebo

EXPERIMENTAL

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.

Diagnostic Test: Urea; Diagnostic Test: Placebo

Study Part 1 placebo followed by urea

EXPERIMENTAL

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.

Diagnostic Test: Urea; Diagnostic Test: Placebo

Study part 2 Urea

EXPERIMENTAL

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

Diagnostic Test: Urea

Interventions

Urea DIAGNOSTIC_TEST

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.

Study Part 1 placebo followed by urea; Study Part 1 urea followed by placebo; Study part 2 Urea

Placebo DIAGNOSTIC_TEST

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®.

Study Part 1 placebo followed by urea; Study Part 1 urea followed by placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Healthy with no medication except hormonal contraception

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Diabetes Insipidus, Neurogenic; Polydipsia, Psychogenic; Diabetes Insipidus

Interventions

Blood Urea Nitrogen

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Polydipsia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Kidney Function Tests; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Mirjam Christ-Crain, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, placebo-controlled cross-over proof-of-concept and pilot study

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 6, 2023
• Study Start: June 2, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CH (1)