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NCT Number: NCT02823613

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

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men aged 20-40
  • Body Mass Index (BMI, weight/height^2) between 18 and 25.

Exclusion criteria

  • Increased blood pressure (hypertension) or in treatment for high blood pressure
  • Diabetes
  • Regular medical intake
  • Smoking
  • Expectation of lacking cooperation or lack of understanding of the experiment
  • Clinical relevant organic or systemic disease including malign disease
  • Decreased kidney function

Treatment and study plan

High salt diet followed by low salt diet

Dietary Supplement

High salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days.

Low salt diet followed by high salt diet

Dietary Supplement

Low salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days.

Primary outcomes

  1. Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes

    Time frame: After 5 days on high or low salt diet

    Semiquantitative western blotting

Secondary outcomes

  1. Plasma aldosterone

    Time frame: Before study start and after 5 days on high or low salt diet

    Concentration in plasma.

  2. Renin

    Time frame: Before study start and after 5 days on high or low salt diet

    Concentration in plasma.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Beckett Foundation
  • Danish Diabetes Academy
  • Odense University Hospital

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2016
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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