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

Phase 4TerminatedNCT01349114

University of Alabama at Birmingham21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Diabetes Pre-hypertension Hypertension

Interventions

aliskiren 300 mg once dailyDRUG

aliskiren 300 mg daily

Placebo/sugar pillDRUG

Sugar pill/placebo

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

UAB

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change in Flow-mediated Dilation

Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion

Time frame: Baseline to 3 months

Secondary Outcomes

Mean Central Aortic Pressure at 3 Months

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)

Time frame: 3 months after start of study

Data from ClinicalTrials.gov

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