The Effect of Renin Inhibition on Nerve Function in Diabetes

NCT00935064 | Completed Results

• 2 other identifiers: 29011NIH (INBRE 2-P20-RR016472-09)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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., \[1\] 30 participants enrolled and randomized to 300 mg of Aliskiren; \[2\] 30 participants enrolled and randomized to placebo).

Conditions

Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (5)

• Systolic Blood Pressure Before and After Treatment

  Systolic blood pressure at baseline and follow-up

  baseline and 6 weeks

• Diastolic Blood Pressure Before and After Treatment

  Diastolic blood pressure at baseline and follow-up.

  baseline and 6 weeks

• Serum Renin Level Before and After Treatment

  Serum renin level at baseline and follow-up

  baseline and 6 weeks

• 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

• 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

Study Arms (2)

Aliskiren

ACTIVE COMPARATOR

Pill, 300 mg, once daily, for 6 weeks

Drug: Aliskiren; Other: Placebo

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Aliskiren DRUG

Pill, 300 mg, once daily, for 6 weeks

Aliskiren

Placebo OTHER

Placebo orally one tablet once a day for 6 weeks.

Aliskiren; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals \>18 years old with type 1 or type 2 diabetes mellitus.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Raelene E. Maser
• Organization: University of Delaware/Christiana Care Health System

rmaser@udel.edu

302-831-8400

Study Officials

• Raelene E Maser, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: August 9, 2016
• Results First Posted: April 1, 2013

Record last verified: 2016-07

Locations

US (1)