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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Nephropathies, Hypertension

Intervention / Treatment
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* Dietary Supplement: Standardized salt diet
* Drug: Amiloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nephropathy<br>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<br>* 200 mmol NaCl per day given as three meals daily for 4 consecutive days.<br>Drug: Amiloride<br>* Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.<br>* Other names: Triamterene;|
| Experimental: Control<br>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<br>* 200 mmol NaCl per day given as three meals daily for 4 consecutive days.<br>Drug: Amiloride<br>* Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.<br>* Other names: Triamterene;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Nephropathies, Hypertension, Proteinuria, Albuminuria, Epithelial Sodium Channels, Epithelial Sodium Channel Blockers, Amiloride