The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion

Not Applicable

Completed

• Conditions: Nocturnal Enuresis; Gender Difference in V2 Receptor Function in Response to dDAVP Infusion; Nocturia
• Interventions: Drug: dDAVP infusion

• Registration Number: NCT02068560
• Lead Sponsor: University of Aarhus

Brief Summary

There is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference.

The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP.

Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Status Verified: 2014-02
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Healthy
• Normal clinical examination
• Normal residual urine measurements
• Normal urine dip stick
• Informed consent by participant or legal guardian

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Exclusion Criteria

• Smoking, alcohol or drug abuse
• Conditions of importance to the results (endocrinological, renal or cardial)
• Current or previous history of incontinence, bedwetting or nocturia
• Drug use of importance (diuretics, hormone replacement therapy, birth control pills, desmopressin)
• Pregnancy
• Allergy towards dDAVP/desmopressin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dDAVP infusion	dDAVP infusion	During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg).

Primary Outcome Measures

Name	Time	Method
Plasma dDAVP	Plasma concentrations of the synthetic hormone is measured every 90 minutes for the first 8 hours and every half hour, the last hour of the study period
Urine Volume	Urine Volume is measured every half hour throughout the 9 hours study period
Urine osmolality	Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day

Secondary Outcome Measures

Name	Time	Method
Plasma sodium	Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark