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Clinical Trial Details

Trial ID: L6472
Source ID: NCT01165983
Associated Drug: Placebo
Title: The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01165983/results
Conditions: Diabetes Type 2
Interventions: DRUG: Placebo|DRUG: Aliskiren
Outcome Measures: Primary: Flow Mediated Vasodilation, 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., Baseline|Flow Mediated Vasodilation, 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., 12 Weeks post-randomization|Nitroglycerin Induced Dilation, Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG., Baseline|Nitroglycerine Induced Vasodilation, Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG., 12 Weeks post-randomization|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside, Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside., Baseline|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside, Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP)., 12 Weeks post-randomization | Secondary: 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 Biochemical Markers of Endothelial Function, C-reactive Protein, μg/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, Osteoprotegerin, pg/mL, 12 Weeks post-randomization|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, 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 Inflammatory Cytokines and Growth Factors, GM-CSF 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, MDC ng/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, TNFα, pg/mL, 12 Weeks post-randomization
Sponsor/Collaborators: Sponsor: Beth Israel Deaconess Medical Center | Collaborators: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 124
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2009-11
Completion Date:
Results First Posted: 2015-02-09
Last Update Posted: 2017-03-28
Locations: Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory, Boston, Massachusetts, 02215, United States
URL: https://clinicaltrials.gov/show/NCT01165983