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Watershift - Pilot Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04520477
Acronym
WATERSHIFT
Enrollment
19
Registered
2020-08-20
Start date
2018-07-01
Completion date
2019-07-01
Last updated
2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal Polyuria, Total Body Water

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).

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.

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Observing the absorption time, and the lay over time from deuterated water from the gast of deuterated water in the blood3 hoursAim 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 switch5 minutesDecrease of impedance by 1 amplitude by changing positions grom standing to lying.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026