Investigating the effects of mannitol on copeptin levels in healthy adults and patients with polyuria-polydipsia syndrome
Official title: Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome: a Double-blind, Randomized Crossover Proof-of-concept and Open-label Single Arm Pilot Study (MARS Study)
Run by University Hospital, Basel, Switzerland · NCT06542198 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if mannitol can help increase copeptin levels in healthy adults and patients with polyuria-polydipsia syndrome to see if it could be a better option for diagnosing these conditions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06542198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with diagnosed primary polydipsia or arginine vasopressin deficiency.
✕Probably not a fit
Patients with uncontrolled diabetes mellitus, urinary tract obstruction, or those with disordered drinking habits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore whether mannitol infusion can stimulate the release of copeptin in both healthy adults and patients diagnosed with polyuria-polydipsia syndrome, which includes arginine vasopressin deficiency and primary polydipsia. The research is divided into two parts: the first part is a double-blind, randomized cross-over proof-of-concept study in healthy individuals, while the second part is an open-label pilot study in patients with diagnosed conditions. The goal is to determine if mannitol can serve as a viable alternative to the current hypertonic saline infusion method for diagnosing these conditions.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more comfortable diagnostic method for patients with polyuria-polydipsia syndrome.
How similar studies have gone: While mannitol has been shown to stimulate AVP release, this specific approach to measuring copeptin levels after mannitol stimulation has not been previously tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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University Hospital Basel
Basel, Switzerland Recruiting
Study contacts
- Principal investigator: Mirjam Christ-Crain, Prof. Dr. med. — University Hospital, Basel, Switzerland
- Study coordinator: Sven Lustenberger
- Email: sven.lustenberger@usb.ch
- Phone: +41 61 328 62 64
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Copeptin test after mannitol vs hypertonic saline to diagnose PPS
This study tests whether a mannitol-based test can diagnose the cause of polyuria-polydipsia syndrome as accurately as the current hypertonic saline test, and which method patients prefer.
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This pilot will test whether a single oral dose of combined estrogen/progestin boosts oxytocin release in young people with pituitary-related hormone deficiencies and matched controls.
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This trial will test whether a nasal oxytocin spray can improve sexual well‑being, arousal, intimacy and related emotions in adults with arginine vasopressin deficiency and in matched healthy adults.
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Effects of intranasal oxytocin on emotion recognition and stress in diabetes insipidus patients
This study is testing if a nasal spray of oxytocin can help people with diabetes insipidus better recognize emotions and lower their stress levels compared to a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.