Investigating the effects of mannitol on copeptin levels in healthy adults and patients with polyuria-polydipsia syndrome
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)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06542198 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diagnosed primary polydipsia or arginine vasopressin deficiency.
Not a fit: Patients with uncontrolled diabetes mellitus, urinary tract obstruction, or those with disordered drinking habits may not benefit from this study.
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 performed: While mannitol has been shown to stimulate AVP release, this specific approach to measuring copeptin levels after mannitol stimulation has not been previously tested.
Eligibility criteria
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 this trial is running
Basel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.