Watershift - Pilot Study (WATERSHIFT)
Primary Purpose
Total Body Water, Nocturnal Polyuria
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bio Impedance assesement (BIA)
Blood and salava sample
Ingestion of deuterated water
Urine sample
Sponsored by
About this trial
This is an interventional basic science trial for Total Body Water
Eligibility Criteria
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
Sites / Locations
- Department of Urology, Ghent University
Outcomes
Primary Outcome Measures
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.
Observing impedance changes linked with position switch
Decrease of impedance by 1 amplitude by changing positions grom standing to lying.
Secondary Outcome Measures
Full Information
NCT ID
NCT04520477
First Posted
August 11, 2020
Last Updated
August 17, 2020
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04520477
Brief Title
Watershift - Pilot Study
Acronym
WATERSHIFT
Official Title
Watershift - Pilot Study: Observing the Interindividual Effects and Mechanims of the Uptake, Storage and Excretion of Water
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Body Water, Nocturnal Polyuria
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Bio Impedance assesement (BIA)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood and salava sample
Intervention Description
Blood Samples were done at the initation of the protocol, and every 10 minutes after ingestion of the deutarated water
Intervention Type
Dietary Supplement
Intervention Name(s)
Ingestion of deuterated water
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Urine sample
Intervention Description
A urine sample is taken at the initiation and after termination of the protocol.
Primary Outcome Measure Information:
Title
Observing the absorption time, and the lay over time from deuterated water from the gast of deuterated water in the blood
Description
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
Title
Observing impedance changes linked with position switch
Description
Decrease of impedance by 1 amplitude by changing positions grom standing to lying.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Urology, Ghent University
City
Gent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Watershift - Pilot Study
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