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Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease

Information source: University of Southern Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Nephropathies; Hypertension

Intervention: Standardized salt diet (Dietary Supplement); Amiloride (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: University of Southern Denmark

Official(s) and/or principal investigator(s):
Henrik Andersen, MD, Principal Investigator, Affiliation: University of Southern Denmark
Jan Erik Henriksen, MD, PhD, Study Director, Affiliation: Odense University Hospital
Claus Bistrup, MD, PhD, Study Director, Affiliation: Odense University Hospital
Boye L Jensen, MD, PhD, Study Director, Affiliation: University of Southern Denmark

Summary

The purpose of the study is to determine whether a diuretic drug called amiloride is capable of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients with kidney disease. Our hypothesis states that amiloride is capable of reducing blood pressure in these patients and thus decrease the cardiovascular risk associated with diabetic kidney disease.

Clinical Details

Official title: Increased Activity of the Epithelial Sodium Channel (ENaC) in Diabetic Nephropathy

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: 24-hour urinary sodium excretion induced by amiloride

Secondary outcome: Office blood pressure measurements

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 1 diabetes

- Negative pregnancy test at inclusion and taking contraceptive medication

- One group with diabetic nephropathy and overt proteinuria

- One normoalbuminuric group without nephropathy

- Creatinine clearance > 40 ml/min

Exclusion Criteria:

- Type 2 diabetes

- Receiving amiloride, glucocorticoids, aldosterone or spironolactone

- Clinically relevant organic or systemic disease including malignancy

Locations and Contacts

Cardiovascular and Renal Research, Odense DK-5000, Denmark
Additional Information

Related publications:

Svenningsen P, Bistrup C, Friis UG, Bertog M, Haerteis S, Krueger B, Stubbe J, Jensen ON, Thiesson HC, Uhrenholt TR, Jespersen B, Jensen BL, Korbmacher C, Skøtt O. Plasmin in nephrotic urine activates the epithelial sodium channel. J Am Soc Nephrol. 2009 Feb;20(2):299-310. doi: 10.1681/ASN.2008040364. Epub 2008 Dec 10.

Svenningsen P, Uhrenholt TR, Palarasah Y, Skjødt K, Jensen BL, Skøtt O. Prostasin-dependent activation of epithelial Na+ channels by low plasmin concentrations. Am J Physiol Regul Integr Comp Physiol. 2009 Dec;297(6):R1733-41. doi: 10.1152/ajpregu.00321.2009. Epub 2009 Sep 30.

Saha C, Eckert GJ, Ambrosius WT, Chun TY, Wagner MA, Zhao Q, Pratt JH. Improvement in blood pressure with inhibition of the epithelial sodium channel in blacks with hypertension. Hypertension. 2005 Sep;46(3):481-7. Epub 2005 Aug 22. Review.

Buhl KB, Friis UG, Svenningsen P, Gulaveerasingam A, Ovesen P, Frederiksen-Møller B, Jespersen B, Bistrup C, Jensen BL. Urinary plasmin activates collecting duct ENaC current in preeclampsia. Hypertension. 2012 Nov;60(5):1346-51. doi: 10.1161/HYPERTENSIONAHA.112.198879. Epub 2012 Sep 17.

Starting date: October 2013
Last updated: October 14, 2013

Page last updated: August 23, 2015

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