NCT02823613

The Influence of High and Low Salt on Exosomes in the Urine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is upregulated in conditions with low salt.

Detailed description

Methods: Exosomes will be isolated from spot urine by ultracentrifugation and tested using western blotting. In-house developed antibodies against different parts of the ENaC gamma subunit as well as commercial antibodies will be used. A marker for exosomes will validate the presence of exosomes in the urine. Power considerations: In this cross over salt-intervention study with quantification of ENaC the investigators refer to a published study regarding the sodium-chloride co-transporter (NCC) in the kidney, were rats where given aldosterone infusion or a low salt diet. In this study n=6 was sufficient to detect a 2-3 fold change in NCC in urinary exosomes. Furthermore 5 patients with primary aldosteronism had a significant increase in NCC in urinary exosomes (N. Lubbe et al, Hypertension 2012). On the basis of this the investigators choose to test 10 persons, but are not able to make a regular power calculation.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High salt diet followed by low salt diet	High salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days.
DIETARY_SUPPLEMENT	Low salt diet followed by high salt diet	Low salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-05-01
• Completion: 2019-05-23
• First posted: 2016-07-06
• Last updated: 2020-04-07

Locations

1 site across 1 country: Denmark