The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes

Not Applicable

Completed

• Conditions: Diabetes Type 2
• Interventions: Drug: Placebo; Drug: Aliskiren

• Registration Number: NCT01165983
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The purpose of this research is to study and determine the effects of Aliskiren on blood vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial function by 30% or more in comparison to the placebo group.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Primary Completion: 2012-01
• Results First Submitted: 2014-11-10
• Results First Submitted QC: 2015-01-26
• Results First Posted: 2015-02-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Aliskiren	Aliskiren	-

Primary Outcome Measures

Name	Time	Method
Flow Mediated Vasodilation	12 Weeks post-randomization	Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Nitroglycerine Induced Vasodilation	12 Weeks post-randomization	Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside	12 Weeks post-randomization	Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).
Nitroglycerin Induced Dilation	Baseline	Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.

Secondary Outcome Measures

Name	Time	Method
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL	12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL	12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL	12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL	12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL	12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL	12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL	12 Weeks post-randomization

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory; 🇺🇸 Boston, Massachusetts, United States