N/A
Completed N=60
The Effect of Renin Inhibition on Nerve Function in Diabetes
Source: ClinicalTrials.gov NCT00935064 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Systolic Blood Pressure Before and After Treatment — 121.0; 124.1; 112.1; 121.5 mm Hg
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., [1] 30 participants enrolled and randomized to 300 mg of Aliskiren; [2] 30 participants enrolled and randomized to placebo).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure Before and After Treatment |
121.0; 124.1; 112.1; 121.5 | — |
| PRIMARY Diastolic Blood Pressure Before and After Treatment |
66.1; 68.2; 61.5; 66.7 | — |
| PRIMARY Serum Renin Level Before and After Treatment |
2.4; 3.1; 0.5; 2.6 | — |
| PRIMARY Mean Circular Resultant Before and After Treatment |
41.8; 38.2; 50.8; 37.5 | — |
| PRIMARY Expiration/Inspiration Ratio Before and After Treatment |
1.22; 1.21; 1.28; 1.20 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00935064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.