Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome (MARS Study)
NCT Number: NCT06542198
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polyuria-polydipsia Syndrome|Arginine Vasopressin Deficiency|Primary Polydipsia
Interventions: DIAGNOSTIC_TEST: Mannitol Infusion (blinded)|DIAGNOSTIC_TEST: Placebo Infusion (blinded)|DIAGNOSTIC_TEST: Mannitol Infusion (open label)
Sponsor: University Hospital, Basel, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2025-12
Locations: University Hospital Basel, Basel, 4031, Switzerland

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).

Primary Outcome Measures: Difference in copeptin levels, The difference in copeptin levels at 90 minutes following a 30-minute infusion of mannitol, part 1: compared to placebo in healthy adults and part 2: between patients with (primary polydipsia) PP and arginine vasopressin deficiency (AVP-D), At 90 min post infusion
Secondary Outcome Measures: Change of copeptin levels, Changes in copeptin levels compared to baseline., At baseline, 30, 45, 60, 90, and 150 min after infusion|Maximum copeptin levels, The maximum copeptin level after infusion is determined., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of hormone level, To determine the change in hormone levels, an assessment of hormones (e.g. Adrenocorticotropic hormone, Growth hormone, Insulin-like growth factor 1) is performed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of serum electrolytes, To determine the change in electrolytes, an assessment of electrolytes (e.g. sodium potassium, chloride) in the serum is performed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of plasma osmolality, To determine the change in parameters associated with fluid balance/ kidney function, an assessment of plasma osmolality (mOsm/kg) is performed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of urea, To determine the change in parameters associated with fluid balance/ kidney function, an assessment of ureal levels (mmol/L) is performed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of uric acid, To determine the change in parameters associated with fluid balance/ kidney function, an assessment of uric acid levels (umol/L) is performed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of creatinine, To determine the change in parameters associated with fluid balance/ kidney function, an assessment of creatinine levels (umol/L) is performed., At baseline, 90, and 150 min after infusion|Assessment of glucose, To determine the change in parameters associated with fluid balance/ kidney function, an assessment of glucose levels (mmol/L) is performed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of urine parameters, To determine the change in urine parameters, an assessment of parameters (e.g. sodium, osmolality, creatinine) in the urine is performed., At baseline, 90 and 150 min after infusion|Assessment of blood pressure, To determine the change of vital parameters, the blood pressure (systolic and diastolic) is assessed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of heart rate, To determine the change of vital parameters, the heart rate is assessed., At baseline, 30, 45, 60, 90, and 150 min after infusion|Assessment of adverse effects, The incidence of adverse effects, such as nausea, headache, fatigue, dizziness, thirst, is assessed using the numeric rating scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain.", At baseline, 30, 45, 60, 90, and 150 min after infusion