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

University of Southern Denmark (SDU)

Status: Unknown

Conditions: Hypertension; Diabetic Nephropathies

Treatments: Dietary Supplement: Standardized salt diet; Drug: Amiloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01918488

2013-052

13-04-R94-A4513-22770 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Nephropathy

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Standardized salt diet

Drug: Amiloride

Control

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Standardized salt diet

Drug: Amiloride