Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease
Primary Purpose
Diabetic Nephropathies, Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Standardized salt diet
Amiloride
Sponsored by
About this trial
This is an interventional basic science trial for Diabetic Nephropathies focused on measuring Diabetic Nephropathies, Hypertension, Proteinuria, Albuminuria, Epithelial Sodium Channels, Epithelial Sodium Channel Blockers, Amiloride
Eligibility 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
Sites / Locations
- Cardiovascular and Renal Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nephropathy
Control
Arm Description
Diabetics 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.
Diabetics 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.
Outcomes
Primary Outcome Measures
24-hour urinary sodium excretion induced by amiloride
Secondary Outcome Measures
Office blood pressure measurements
Full Information
NCT ID
NCT01918488
First Posted
July 31, 2013
Last Updated
October 14, 2013
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Region of Southern Denmark, The Ministry of Science, Technology and Innovation, Denmark, Danish Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01918488
Brief Title
Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease
Official Title
Increased Activity of the Epithelial Sodium Channel (ENaC) in Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Region of Southern Denmark, The Ministry of Science, Technology and Innovation, Denmark, Danish Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies, Hypertension
Keywords
Diabetic Nephropathies, Hypertension, Proteinuria, Albuminuria, Epithelial Sodium Channels, Epithelial Sodium Channel Blockers, Amiloride
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nephropathy
Arm Type
Experimental
Arm Description
Diabetics 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.
Arm Title
Control
Arm Type
Experimental
Arm Description
Diabetics 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standardized salt diet
Intervention Description
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Amiloride
Other Intervention Name(s)
Triamterene
Intervention Description
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
Primary Outcome Measure Information:
Title
24-hour urinary sodium excretion induced by amiloride
Time Frame
Change from baseline urinary sodium excretion at 24 hours after amiloride administration
Secondary Outcome Measure Information:
Title
Office blood pressure measurements
Time Frame
Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Andersen, MD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Erik Henriksen, MD, PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claus Bistrup, MD, PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Boye L Jensen, MD, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Cardiovascular and Renal Research
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19073825
Citation
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.
Results Reference
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PubMed Identifier
19793956
Citation
Svenningsen 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.
Results Reference
background
PubMed Identifier
16116042
Citation
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. doi: 10.1161/01.HYP.0000179582.42830.1d. Epub 2005 Aug 22.
Results Reference
background
PubMed Identifier
22987920
Citation
Buhl 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.
Results Reference
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Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease
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