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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Henrik Andersen, MD, University of Southern Denmark.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01918488
First Posted: August 7, 2013
Last Update Posted: October 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Odense University Hospital
Region of Southern Denmark
The Ministry of Science, Technology and Innovation, Denmark
Danish Heart Foundation
Information provided by (Responsible Party):
Henrik Andersen, MD, University of Southern Denmark
  Purpose
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.

Condition Intervention
Diabetic Nephropathies Hypertension Dietary Supplement: Standardized salt diet Drug: Amiloride

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Increased Activity of the Epithelial Sodium Channel (ENaC) in Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Henrik Andersen, MD, University of Southern Denmark:

Primary Outcome Measures:
  • 24-hour urinary sodium excretion induced by amiloride [ Time Frame: Change from baseline urinary sodium excretion at 24 hours after amiloride administration ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nephropathy
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.
Dietary Supplement: Standardized salt diet
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
Drug: Amiloride
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
Other Name: Triamterene
Experimental: Control
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.
Dietary Supplement: Standardized salt diet
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
Drug: Amiloride
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
Other Name: Triamterene

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918488


Locations
Denmark
Cardiovascular and Renal Research
Odense, Denmark, DK-5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Region of Southern Denmark
The Ministry of Science, Technology and Innovation, Denmark
Danish Heart Foundation
Investigators
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
  More Information

Publications:
Responsible Party: Henrik Andersen, MD, MD, PhD student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01918488     History of Changes
Other Study ID Numbers: 2013-052
13-04-R94-A4513-22770 ( Other Grant/Funding Number: The Danish Heart Foundation )
First Submitted: July 31, 2013
First Posted: August 7, 2013
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Henrik Andersen, MD, University of Southern Denmark:
Diabetic Nephropathies
Hypertension
Proteinuria
Albuminuria
Epithelial Sodium Channels
Epithelial Sodium Channel Blockers
Amiloride

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Diabetic Nephropathies
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Amiloride
Epithelial Sodium Channel Blockers
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Diuretics, Potassium Sparing


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