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CompletedNCT04520477WATERSHIFTUpdated Aug 20, 2020

Watershift - Pilot Study

An interventional study of Bio Impedance assesement (BIA) and Blood and salava sample in Total Body Water and Nocturnal Polyuria, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jul 2018, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 30 Years
Sex
All
01

Study 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).
02

Conditions studied

  • Total Body Water
  • Nocturnal Polyuria

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03

In context

Polyuria

14 studies on the registry are indexed under Polyuria; 2 are open to participants now.

Browse Polyuria studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Intake of medications except of OAC
  • Patients with pacemaker or neurostimulator
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Interventions

  • Diagnostic testBio 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.

  • Diagnostic testBlood and salava sample

    Blood Samples were done at the initation of the protocol, and every 10 minutes after ingestion of the deutarated water

  • Dietary supplementIngestion 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 testUrine sample

    A urine sample is taken at the initiation and after termination of the protocol.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 hours

  2. Observing impedance changes linked with position switch

    Decrease of impedance by 1 amplitude by changing positions grom standing to lying.

    Time frame: 5 minutes

07

Study locations

1 site
  • Department of Urology, Ghent University
    Gent, 9000, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04520477
Responsible party
Sponsor
First posted
Aug 20, 2020
Start date
Jul 1, 2018
Primary completion
Dec 1, 2018
Completion
Jul 1, 2019
Last update
Aug 20, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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