Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Synd… (NCT06542198) | Clinical Trial Compass
CompletedNot Applicable
Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome (MARS Study)
Switzerland42 participantsStarted 2024-09-10
Plain-language 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 arginine vasopressin deficiency (part 2: pilot study).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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)
What they're measuring
1
Difference in copeptin levels
Timeframe: Part 1: At 90 min post infusion, Part 2: at 30 min post infusion