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| Name | Class |
|---|---|
| Danish Diabetes Academy | OTHER |
| Odense University Hospital | OTHER |
| Beckett Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy male test subjects 1-5 | Experimental | High salt diet followed by low salt diet |
|
| Healthy male test subjects 6-10 | Experimental | Low salt diet followed by high salt diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes | Semiquantitative western blotting | After 5 days on high or low salt diet |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma aldosterone | Concentration in plasma. | Before study start and after 5 days on high or low salt diet |
| Renin | Concentration in plasma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boye L Jensen, dr.med., phd | Cardiovascular and Renal Research, Institute of Moleculare Medicine, University of Southern Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Denmark | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25060057 | Background | 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. | |
| 22851731 | 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. |
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open label
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| 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. |
|
| Before study start and after 5 days on high or low salt diet |