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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Odense University Hospital
Region Southern Denmark
Ministry of Science, Innovation and Higher Education (Denmark)
Danish Heart Foundation
Information provided by (Responsible Party):
Henrik Andersen, MD, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01918488
First received: July 31, 2013
Last updated: October 14, 2013
Last verified: October 2013
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918488

Locations
Denmark
Cardiovascular and Renal Research
Odense, Denmark, DK-5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Region Southern Denmark
Ministry of Science, Innovation and Higher Education (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
Study First Received: July 31, 2013
Last Updated: October 14, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on October 22, 2014