This proof of principle study is designed to study the excretion of two well-studied transporters, Aquaporin-2 (AQP-2) and the sodium chloride cotransporter (NCC), in urinary exosomes. Both are sensitive to water homeostasis, so that during water…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Fysiologische studie - testen van methodiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be a change in urine osmolality after fasting and
water loading.
Secondary outcome
Change of urine exosomal aquaporin-2 and NCC between fasting and after water
loading. Furthermore the number of excreted exosomes.
Background summary
Urinary exosomes are small vesicles secreted by all epithelial cells lining the
nephron. Their protein content reflects the state of the cells they originate
from, allowing their measurement as a non-invasive biomarker for kidney
physiology and pathology. Current methods to measure exosomal content relies on
ultracentrifugation, which is a time-consuming method requiring large volumes
of urine. A better approach would be the use of an enzyme linked immunosorbent
assay (ELISA) to measure exosomal content.
Study objective
This proof of principle study is designed to study the excretion of two
well-studied transporters, Aquaporin-2 (AQP-2) and the sodium chloride
cotransporter (NCC), in urinary exosomes. Both are sensitive to water
homeostasis, so that during water deprivation or water loading they are
increased or decreased, respectively. Our goal is to measure AQP-2 and NCC in
healthy volunteers after fasting and waterloading. We would like to see if
these changes are detected using our ELISA. Furthermore (in the amendment), we
would like to determine usability of the technique as normalization method by
counting exosomes using a newly available method.
Study design
Volunteers will be asked to fast for 14 hours and subsequently drink water (20
mL/kg in 30 minutes). Urine will be collected at 2 time points during fasting
(10h and 12h) and 3 time points after water loading (1h, 2h and 4h).
Intervention
14 hour fasting and water loading (20 mL/kg body weight in 30 minutes)
Study burden and risks
An overnight water deprivation test will be performed, which may be
inconvenient for the patient. The risk of fasting includes dehydration and
related symptoms, such as excessive thirst, change in mental state and decrease
of blood pressure. However, the risk of dehydration after 14 hour fasting is
negligible. The risks for consuming a water load include electrolyte
imbalances, such as a hyponatremia. In healthy subjects, that are subjected to
20mL/kg body weight, this risk is negligible.
There are no direct benefits associated with participation for the individual
participant.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Have the capacity to understand and willingness to sign an informed consent form.
Aged 18-30 years
Exclusion criteria
- Use of medication
- History of diabetes insipidus, diabetes mellitus, adrenal deficiency, thyroid disease or chronic kidney disease
- Alcohol abuse
- Urinary tract infection or menstruation at the time of inclusion
- Pregnancy or breast feeding
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52107.078.15 |