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

April 6, 2020 updated by: Rikke Zachar Langkilde, University of Southern Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy male test subjects 1-5
High salt diet followed by low salt diet
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.
Experimental: Healthy male test subjects 6-10
Low salt diet followed by high salt diet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes
Time Frame: After 5 days on high or low salt diet
Semiquantitative western blotting
After 5 days on high or low salt diet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma aldosterone
Time Frame: Before study start and after 5 days on high or low salt diet
Concentration in plasma.
Before study start and after 5 days on high or low salt diet
Renin
Time Frame: Before study start and after 5 days on high or low salt diet
Concentration in plasma.
Before study start and after 5 days on high or low salt diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Beckett Foundation
Danish Diabetes Academy

Investigators

  • Study Director: Boye L Jensen, dr.med., phd, Cardiovascular and Renal Research, Institute of Moleculare Medicine, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 23, 2019

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RZL-SDU-IMM-CVR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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