Status:
COMPLETED
Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome (MARS Study)
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Polyuria-polydipsia Syndrome
Arginine Vasopressin Deficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aims of this study are to investigate whether mannitol stimulates copeptin (part 1: proof-of-concept) and whether the copeptin levels upon mannitol infusion differ in primary polydipsia and argini...
Detailed Description
Diagnosing polyuria-polydipsia syndrome, which includes arginine vasopressin (AVP) deficiency (AVP-D, formerly central diabetes insipidus) and primary polydipsia (PP), is challenging but essential. Cu...
Eligibility Criteria
Inclusion
- Part 1: Proof of Concept in Healthy adults
- Age ≥ 18 years
- Healthy with no medication except hormonal contraception
- Part 2: Pilot Study in Patients with primary polydipsia (PP) or arginine vasopressin deficiency (AVP-D)
- Age ≥ 18 years
- Evidence of polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 Liter per 24 hours or regular desmopressin medication corresponding to a diagnosis of PP or AVP-D
Exclusion
- Part 1: Proof of Concept in Healthy adults
- Participation in a trial with investigational drugs within 30 days
- Evidence of disordered drinking habits and diuresis defined as polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 Liter per 24 hours.
- Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1,73 m2
- Glucose \> 11.1 mmol/L corresponding to the diagnosis of an uncontrolled diabetes mellitus
- History of urinary tract obstruction
- Problems with urination
- Pregnancy or breastfeeding
- Multiple allergies (≥ 3)
- Evidence of acute illness
- Part 2: Pilot Study in Patients with PP or AVP-D
- Participation in a trial with investigational drugs within 30 days
- Pregnancy or breastfeeding
- Evidence of acute illness
- eGFR \< 60 ml/min/1,73 m2
- Glucose \> 11.1 mmol/L corresponding to the diagnosis of uncontrolled diabetes mellitus
- History of urinary tract obstruction
- Problems with urination
- Therapy with diuretics
- Multiple allergies (≥ 3)
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06542198
Start Date
September 10 2024
End Date
July 22 2025
Last Update
December 15 2025
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031