The Effect of Renin Inhibition on Nerve Function in Diabetes

Diabetes Clinical Trial

Official title:

Effect of Renin Inhibition on Cardiovascular Autonomic Nerve Function in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935064
• Other study ID #: 29011
• Secondary ID: NIH (INBRE 2-P20
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: December 8, 2015
• Start date: June 2009
• Est. completion date: April 2012

Study information

• Verified date: December 2015
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Aliskiren
Pill, 300 mg, once daily, for 6 weeks

Other:
• Placebo
Placebo orally one tablet once a day for 6 weeks.

Locations

Country	Name	City	State
United States	Christiana Care Health Services	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure Before and After Treatment	Systolic blood pressure at baseline and follow-up	baseline and 6 weeks	No
Primary	Diastolic Blood Pressure Before and After Treatment	Diastolic blood pressure at baseline and follow-up.	baseline and 6 weeks	No
Primary	Serum Renin Level Before and After Treatment	Serum renin level at baseline and follow-up	baseline and 6 weeks	No
Primary	Mean Circular Resultant Before and After Treatment	Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable.	baseline and 6 weeks	No
Primary	Expiration/Inspiration Ratio Before and After Treatment	Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles.	baseline and 6 weeks	No