Status:
COMPLETED
The Effect of Renin Inhibition on Nerve Function in Diabetes
Lead Sponsor:
Christiana Care Health Services
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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., \[...
Eligibility Criteria
Inclusion
- Individuals \>18 years old with type 1 or type 2 diabetes mellitus.
Exclusion
- 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).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00935064
Start Date
June 1 2009
End Date
April 1 2012
Last Update
August 9 2016
Active Locations (1)
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1
Christiana Care Health Services
Newark, Delaware, United States, 19713