The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
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|ClinicalTrials.gov Identifier: NCT02068560|
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : December 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Gender Difference in V2 Receptor Function in Response to dDAVP Infusion Nocturia Nocturnal Enuresis||Drug: dDAVP infusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: 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).
Drug: dDAVP infusion
- Urine osmolality [ Time Frame: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day ]
- Urine Volume [ Time Frame: Urine Volume is measured every half hour throughout the 9 hours study period ]
- Plasma dDAVP [ Time Frame: 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 ]
- Plasma sodium [ Time Frame: Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068560
|Aarhus University Hospital|
|Aarhus, Denmark, 8000|