Watershift - Pilot Study

Nocturnal Polyuria Clinical Trial

— WATERSHIFT  

Official title:

Watershift - Pilot Study: Observing the Interindividual Effects and Mechanims of the Uptake, Storage and Excretion of Water

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520477
• Other study ID #: EC2017/1636
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Nocturnal Polyuria
• Polyuria
• Total Body Water

Intervention

Diagnostic Test:
• Bio Impedance assesement (BIA)
BIA every 5 minutes od the test protocol. Patients stood up for 5 minutes, laid down for 70 minutes, followed by 5 minutes in a seated position and ending with 30 minutes standing. BIA was done every 5 minutes.
• Blood and salava sample
Blood Samples were done at the initation of the protocol, and every 10 minutes after ingestion of the deutarated water

Dietary Supplement:
• Ingestion of deuterated water
15 minutes after the intiation of the test protocol, participants drink an amount of deuterated water corresponding with 0.25% of their TBW calculated using the Watson Formula

Diagnostic Test:
• Urine sample
A urine sample is taken at the initiation and after termination of the protocol.

Locations

Country	Name	City	State
Belgium	Department of Urology, Ghent University	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observing the absorption time, and the lay over time from deuterated water from the gast of deuterated water in the blood	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.	3 hours
Primary	Observing impedance changes linked with position switch	Decrease of impedance by 1 amplitude by changing positions grom standing to lying.	5 minutes