The Effect of Renin Inhibition on Nerve Function in Diabetes

Christiana Care Health Services

Status

Completed

Conditions

Diabetes

Treatments

Drug: Aliskiren

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00935064

29011

NIH (INBRE 2-P20-RR016472-09)

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).