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

NCT02823613 | Completed DMC

• 1 other identifier: RZL-SDU-IMM-CVR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

ENaC; Exosomes; Urinary biomarker; Salt regulation

Outcome Measures

Primary Outcomes (1)

• Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes

  Semiquantitative western blotting

  After 5 days on high or low salt diet

Secondary Outcomes (2)

• Plasma aldosterone

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

• Renin

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

Study Arms (2)

Healthy male test subjects 1-5

EXPERIMENTAL

High salt diet followed by low salt diet

Dietary Supplement: High salt diet followed by low salt diet

Healthy male test subjects 6-10

EXPERIMENTAL

Low salt diet followed by high salt diet

Dietary Supplement: Low salt diet followed by high salt diet

Interventions

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.

Healthy male test subjects 1-5

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.

Healthy male test subjects 6-10

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Danish Diabetes Academy: collaborator
• Odense University Hospital: collaborator
• Beckett Foundation: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5000, Denmark

Location

Related Publications (2)

• Zachar RM, Skjodt K, Marcussen N, Walter S, Toft A, Nielsen MR, Jensen BL, Svenningsen P. The epithelial sodium channel gamma-subunit is processed proteolytically in human kidney. J Am Soc Nephrol. 2015 Jan;26(1):95-106. doi: 10.1681/ASN.2013111173. Epub 2014 Jul 24.

  PMID: 25060057 BACKGROUND

• van der Lubbe N, Jansen PM, Salih M, Fenton RA, van den Meiracker AH, Danser AH, Zietse R, Hoorn EJ. The phosphorylated sodium chloride cotransporter in urinary exosomes is superior to prostasin as a marker for aldosteronism. Hypertension. 2012 Sep;60(3):741-8. doi: 10.1161/HYPERTENSIONAHA.112.198135. Epub 2012 Jul 30.

  PMID: 22851731 BACKGROUND

Study Officials

• Boye L Jensen, dr.med., phd

  Cardiovascular and Renal Research, Institute of Moleculare Medicine, University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd student

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 6, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 23, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)