The Effect of Renin Inhibition on Nerve Function in Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-04-30

Brief Summary

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This study will assess the effect of direct renin inhibition on nerve function in persons with diabetes using a double-blind, placebo-controlled randomized trial involving two treatment arms (i.e., \[1\] 30 participants enrolled and randomized to 300 mg of Aliskiren; \[2\] 30 participants enrolled and randomized to placebo).

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aliskiren

Pill, 300 mg, once daily, for 6 weeks

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

Pill, 300 mg, once daily, for 6 weeks

Placebo

Intervention Type OTHER

Placebo orally one tablet once a day for 6 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo orally one tablet once a day for 6 weeks.

Interventions

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Aliskiren

Pill, 300 mg, once daily, for 6 weeks

Intervention Type DRUG

Placebo

Placebo orally one tablet once a day for 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals \>18 years old with type 1 or type 2 diabetes mellitus.

Exclusion Criteria

* Individuals currently taking the maximum dose of an ACE inhibitor or an ARB.
* Individuals with a history of a MI, percutaneous coronary interventions, coronary artery bypass graft (CABG) surgery, acute coronary syndromes, recent/on going atrial fibrillation, frequent atrial arrhythmias, frequent ventricular arrhythmias, or acute myocardial ischemia changes.
* Individuals whose treatment dosage changes 2 months prior to the study for antihypertensive and antidiabetes medications, and the following medications that may affect the ANS: anti-tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol, perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin, barbiturates, neuroleptic, antiparkinsonism drugs, and nitrated drugs.
* Pregnant or lactating females.
* Individuals with impaired renal function (i.e., creatinine \>1.5 mg/dl), a history of dialysis, nephritic syndrome or renovascular hypertension.
* Individuals with potassium levels within 0.5 mmol/L of the upper limit of normal (i.e., hyperkalemia).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No