Skip to main content
OpenTrials
Completed

NCT Number: NCT00935064

The Effect of Renin Inhibition on 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aliskiren

Drug

Pill, 300 mg, once daily, for 6 weeks

Placebo

Other

Placebo orally one tablet once a day for 6 weeks.

Primary outcomes

  1. Systolic Blood Pressure Before and After Treatment

    Time frame: baseline and 6 weeks

    Systolic blood pressure at baseline and follow-up

  2. Diastolic Blood Pressure Before and After Treatment

    Time frame: baseline and 6 weeks

    Diastolic blood pressure at baseline and follow-up.

  3. Serum Renin Level Before and After Treatment

    Time frame: baseline and 6 weeks

    Serum renin level at baseline and follow-up

  4. Mean Circular Resultant Before and After Treatment

    Time frame: baseline and 6 weeks

    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.

  5. Expiration/Inspiration Ratio Before and After Treatment

    Time frame: baseline and 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Effect of Renin Inhibition on Cardiovascular Autonomic Nerve Function in Diabetes

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 8, 2009
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.