The Effect of Renin Inhibition on Nerve Function in Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2009 |
| End Date: | April 2012 |
Effect of Renin Inhibition on Cardiovascular Autonomic Nerve Function in Diabetes
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).
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).
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).
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