Watershift - Pilot Study

Not Applicable

Completed

• Conditions: Total Body Water; Nocturnal Polyuria

• Registration Number: NCT04520477
• Lead Sponsor: University Hospital, Ghent

Brief Summary

The aim of this pilot was to study how body water behaves between the different internal water pools of the human body, what the role and influence of the interstitium is and what the effect is of body position on the distribution and allocation of BW between different body parts (trunk, legs, arms). To study this, 2 techniques that have not been used before in urological research were tested on their usefulness:

* The first technique is a recent BIA device, which distinguishes itself from earlier devices by measuring impedance at different electrical currencies in different body parts (arm/limb/trunk). This technique made it possible to observe the influence of body position on the distribution of BW in these body compartments. Rationale for this research question is mainly the link between NP and edema that was found in earlier research and the fact that body position seemed to have an impact on the size of edema. For this reason, it can be suggested that body position and thus edema will have an impact on whether or not NP occurs.

* The second technique uses deuterium as a biological marker. With this technique the distribution, storage, allocation and excretion of BW was examined among the urological most relevant water pools (blood, urine and interstitium).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-07-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-17
• Last Update Submitted: 2020-08-17
• Study First Posted: 2020-08-20
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Healthy individuals
• Ages between 18 and 30
• BMI between 18 and 24.9

Exclusion Criteria

• Intake of medications except of OAC
• Patients with pacemaker or neurostimulator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Observing the absorption time, and the lay over time from deuterated water from the gast of deuterated water in the blood	3 hours	Aim of this overview is to assess how fast the deuterium oxide ingested in the human gastro-intestinal tractus, the colon and the blood pool. We want to know if this is 5min or even more 30 min and when the maximal dose of deuterium in the blood is reached.
Observing impedance changes linked with position switch	5 minutes	Decrease of impedance by 1 amplitude by changing positions grom standing to lying.

Trial Locations

Locations (1)

Department of Urology, Ghent University; 🇧🇪 Gent, Belgium