Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease
Increased Activity of the Epithelial Sodium Channel (ENaC) in Diabetic Nephropathy
2 other identifiers
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedOctober 16, 2013
October 1, 2013
1.2 years
July 31, 2013
October 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24-hour urinary sodium excretion induced by amiloride
Change from baseline urinary sodium excretion at 24 hours after amiloride administration
Secondary Outcomes (1)
Office blood pressure measurements
Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration
Study Arms (2)
Nephropathy
EXPERIMENTALDiabetics with diabetic nephropathy receiving first a standardized salt diet (200 mmol NaCl/day) for 4 days and then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days.
Control
EXPERIMENTALDiabetics without nephropathy receiving a standardized salt diet (200 mmol NaCl/day) for 4 days, then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days.
Interventions
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
Eligibility Criteria
You may qualify if:
- Type 1 diabetes
- One group with diabetic nephropathy and overt proteinuria
- One normoalbuminuric group without nephropathy
- Creatinine clearance \> 40 ml/min
You may not qualify if:
- Type 2 diabetes
- Receiving amiloride, glucocorticoids, aldosterone or spironolactone
- Clinically relevant organic or systemic disease including malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Odense University Hospitalcollaborator
- Region of Southern Denmarkcollaborator
- The Ministry of Science, Technology and Innovation, Denmarkcollaborator
- Danish Heart Foundationcollaborator
Study Sites (1)
Cardiovascular and Renal Research
Odense, DK-5000, Denmark
Related Publications (5)
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, Skott 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.
PMID: 19073825BACKGROUNDSvenningsen P, Uhrenholt TR, Palarasah Y, Skjodt K, Jensen BL, Skott 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.
PMID: 19793956BACKGROUNDSaha 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. doi: 10.1161/01.HYP.0000179582.42830.1d. Epub 2005 Aug 22.
PMID: 16116042BACKGROUNDBuhl KB, Friis UG, Svenningsen P, Gulaveerasingam A, Ovesen P, Frederiksen-Moller 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.
PMID: 22987920BACKGROUNDIsaksson GL, Hinrichs GR, Andersen H, Bach ML, Weyer K, Zachar R, Henriksen JE, Madsen K, Lund IK, Mollet G, Bistrup C, Birn H, Jensen BL, Palarasah Y. Amiloride Reduces Urokinase/Plasminogen-Driven Intratubular Complement Activation in Glomerular Proteinuria. J Am Soc Nephrol. 2024 Apr 1;35(4):410-425. doi: 10.1681/ASN.0000000000000312. Epub 2024 Jan 23.
PMID: 38254266DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Andersen, MD
University of Southern Denmark
- STUDY DIRECTOR
Jan Erik Henriksen, MD, PhD
Odense University Hospital
- STUDY DIRECTOR
Claus Bistrup, MD, PhD
Odense University Hospital
- STUDY DIRECTOR
Boye L Jensen, MD, PhD
University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student
Study Record Dates
First Submitted
July 31, 2013
First Posted
August 7, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2014
Last Updated
October 16, 2013
Record last verified: 2013-10