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

Not Applicable

• Conditions: Hypertension; Diabetic Nephropathies
• Interventions: Dietary Supplement: Standardized salt diet; Drug: Amiloride

• Registration Number: NCT01918488
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Status Verified: 2013-10
• Study Start: 2013-10
• Last Update Submitted: 2013-10-14
• Last Update Posted: 2013-10-16
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nephropathy	Standardized salt diet	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.
Control	Standardized salt diet	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.
Control	Amiloride	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.
Nephropathy	Amiloride	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.

Primary Outcome Measures

Name	Time	Method
24-hour urinary sodium excretion induced by amiloride	Change from baseline urinary sodium excretion at 24 hours after amiloride administration

Secondary Outcome Measures

Name	Time	Method
Office blood pressure measurements	Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration

Trial Locations

Locations (1)

Cardiovascular and Renal Research; 🇩🇰 Odense, Denmark