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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01918488

Enrollment

Registered

2013-08-07

Start date

2013-10-31

Completion date

Unknown

Last updated

2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathies, Hypertension

Keywords

Diabetic Nephropathies, Hypertension, Proteinuria, Albuminuria, Epithelial Sodium Channels, Epithelial Sodium Channel Blockers, Amiloride

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.

Interventions

DIETARY_SUPPLEMENTStandardized salt diet

200 mmol NaCl per day given as three meals daily for 4 consecutive days.

DRUGAmiloride

Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026