The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
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.
Gender Difference in V2 Receptor Function in Response to dDAVP Infusion
Drug: dDAVP infusion
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin 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 ] [ Designated as safety issue: No ]
- Urine Volume [ Time Frame: Urine Volume is measured every half hour throughout the 9 hours study period ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02068560
|Contact: Marie K Schroder, MD||+ 45 78 45 15 firstname.lastname@example.org|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Marie K Schroder, MD + 78 45 15 23 email@example.com|