Watershift - Pilot Study

NCT04520477 | Completed

• 1 other identifier: EC2017/1636
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Total Body Water; Nocturnal Polyuria

Outcome Measures

Primary Outcomes (2)

• 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

• Observing impedance changes linked with position switch

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

  5 minutes

Interventions

Bio Impedance assesement (BIA) DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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

Ingestion of deuterated water DIETARY_SUPPLEMENT

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

Urine sample DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Urology, Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 20, 2020
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

BE (1)