Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Phase 4

Terminated

• Conditions: Diabetes; Pre-hypertension; Hypertension
• Interventions: Drug: aliskiren 300 mg once daily; Drug: Placebo/sugar pill

• Registration Number: NCT01349114
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

Detailed Description

Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.

Study Timeline

• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Study Start: 2011-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-07-11
• Results First Submitted QC: 2014-05-21
• Results First Posted: 2014-06-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Type 2 diabetes
• prehypertension or Stage 1 hypertension

Exclusion Criteria

• Type 1 diabetes
• Stage 2 hypertension
• CKD
• recent MI, revascularization, CVA or TIA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aliskiren 300 mg once daily for 12 weeks	aliskiren 300 mg once daily	aliskiren 300 mg daily
Sugar pill/ placebo	Placebo/sugar pill	Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo

Primary Outcome Measures

Name	Time	Method
Change in Flow-mediated Dilation	Baseline to 3 months	Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion

Secondary Outcome Measures

Name	Time	Method
Mean Central Aortic Pressure at 3 Months	3 months after start of study	Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States