Investigating tolvaptan stimulated copeptin measurements for the differential diagnosis of polyuria-polydipsia syndrome

Not Applicable

• Conditions: Arginine vasopressin deficiency; Polyuria polydipsia syndrome; Primary polydipsia; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12624000191594
• Lead Sponsor: Princess Alexandra Hospital, Metro South Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-27
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Healthy participants
oAge >18 years
oHealthy participant with no significant comorbidities

Participants with arginine vasopressin deficiency or primary polydipsia
- 18 years or older
- BMI 18.5 to 30 kg/m2
- polyuria >3L/day or >50mL/kg body weight/day or regular desmopressin administration.

Exclusion Criteria

Healthy volunteers
oBMI <18.5 kg/m2 or >30 kg/m2
oVigorous physical exercise within 24 hours of study participation
oAlcohol intake or cigarette smoking within 24 hours of study participation
oPregnancy and breastfeeding
oEvidence of disordered drinking habits (polyuria >50 mL/kg body weight and polydipsia >3L/24 hours)
oAcute illness
oElectrolyte abnormalities including hyponatraemia or other electrolyte disorders
oSignificant medical comorbidities (cardiac, hepatic and kidney failure, diabetes mellitus, pituitary or adrenal disorders, untreated hypothyroidism, uncontrolled hypertension and epilepsy)
oConcomitant medications with the potential to interfere with the results (including those known to cause electrolyte disturbances and/or solute diuresis such as diuretics, glucocorticoids, anti-epileptic, anti-depressant and anti-emetic medications).

Participants with arginine vasopressin deficiency or primary polydipsia
o Vigorous exercise <24 hours before study participation
oAlcohol intake or cigarette smoking <24 hours before the study participation, pregnancy or breastfeeding
oAacute illness.
oSignificant medical comorbidities (cardiac, hepatic and kidney failure, diabetes mellitus, pituitary or adrenal disorders, untreated hypothyroidism, uncontrolled hypertension and epilepsy)
oConcomitant medications with the potential to interfere with the results (including those known to cause electrolyte disturbances and/or solute diuresis such as diuretics, glucocorticoids, anti-epileptic, anti-depressant and anti-emetic medications).

Study & Design

• Study Type: Interventional
• Study Design: Not specified