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

Sponsor

University of Southern Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT01918488

Collaborator

Odense University Hospital (Other), Region of Southern Denmark (Other), The Ministry of Science, Technology and Innovation, Denmark (Other), Danish Heart Foundation (Other)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies Hypertension	Dietary Supplement: Standardized salt diet Drug: Amiloride	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

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

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Arms and Interventions

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

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