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

October 14, 2013 updated by: Henrik Andersen, MD, University of Southern Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, DK-5000
        • Cardiovascular and Renal Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Triamterene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-hour urinary sodium excretion induced by amiloride
Time Frame: Change from baseline urinary sodium excretion at 24 hours after amiloride administration
Change from baseline urinary sodium excretion at 24 hours after amiloride administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
The Ministry of Science, Technology and Innovation, Denmark
Region of Southern 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 14, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-052
  • 13-04-R94-A4513-22770 (Other Grant/Funding Number: The Danish Heart Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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