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

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gender Difference in V2 Receptor Function in Response to dDAVP Infusion; Nocturia; Nocturnal Enuresis

Intervention: dDAVP infusion (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Aarhus

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Urine osmolality

Urine Volume

Plasma dDAVP

Secondary outcome: Plasma sodium

Eligibility

Minimum age: 8 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Aarhus University Hospital, Aarhus 8000, Denmark
Additional Information

Starting date: May 2012
Last updated: December 10, 2014

Page last updated: August 23, 2015

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