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

Last updated: July 8, 2024
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Completed

Phase

N/A

Condition

Hormone Deficiencies

Hyponatremia

Treatment

Placebo

Urea

Clinical Study ID

NCT05890690
2023-00751; kt23christcrain2
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Healthy volunteers

Inclusion Criteria:

  • Age ≥18 years

  • Healthy with no medication except hormonal contraception

Exclusion

Exclusion Criteria:

  • Participation in a trial with investigational drugs within 30 days

  • Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kgbody 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., waterdeprivation test, hypertonic saline infusion test or arginine infusion test.Accordingly, patients must have evidence of disordered drinking habits and diuresisdefined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or must be onregular 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

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
June 02, 2023
Estimated Completion Date:
June 24, 2024

Study 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.

Connect with a study center

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

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