The Effect of Renin Inhibition on Nerve Function in Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetes

In brief

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).

Key facts

Study ID

NCT00935064

Run by

Christiana Care Health Services

People needed

60

Starts

2009-06-01

Expected to finish

2012-04-01

Last updated by the study team

2016-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• Christiana Care Health Services — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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