Nocturia Clinical Trial
Official title:
The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
Verified date | February 2014 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 8 Years to 80 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Ferring Pharmaceuticals |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine osmolality | Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day | No | |
Primary | Urine Volume | Urine Volume is measured every half hour throughout the 9 hours study period | No | |
Primary | 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 | No | |
Secondary | 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 | Yes |
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