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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gender Difference in V2 Receptor Function in Response to dDAVP Infusion, Nocturia, Nocturnal Enuresis

Intervention / Treatment
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* Drug: dDAVP infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Normal clinical examination Normal residual urine measurements Normal urine dip stick Informed consent by participant or legal guardian 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dDAVP infusion<br>During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg). | Drug: dDAVP infusion<br> <br> * Other names: minirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine osmolality |  | Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day | 
| Urine Volume |  | Urine Volume is measured every half hour throughout the 9 hours study period | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |