Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431691
Status:
COMPLETED
Last Update Posted:
2008-07-04
First Post:
2007-02-05
Brief Title:
Effect of Antioxidants on Ocular Blood Flow Endothelial Function and Cytokine Levels in LPS Induced Inflammatory Model in Humans
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Effect of Antioxidants on Ocular Blood Flow Endothelial Function and Cytokine Levels in LPS Induced Inflammatory Model in Humans
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oxidative stress which refers to cellular damage caused by reactive oxygen intermediates has been implicated in many disease processes especially age-related disorders Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted but the results are ambiguous
Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction In the present study the infusion of LPS which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock will be used as a standardized experimental model of systemic inflammatory response in humans The assessment of outcome parameters will include measurements of ocular blood flow forearm blood flow and plasma concentration of cytokines Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively Moreover the retina is especially susceptible to oxidative stress because of its high consumption of oxygen its high polyunsaturated fatty acid content and its exposure to visible light Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus The measurement of forearm blood flow will be use to assess endothelial function The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration
Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction In the present study the infusion of LPS which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock will be used as a standardized experimental model of systemic inflammatory response in humans The assessment of outcome parameters will include measurements of ocular blood flow forearm blood flow and plasma concentration of cytokines Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively Moreover the retina is especially susceptible to oxidative stress because of its high consumption of oxygen its high polyunsaturated fatty acid content and its exposure to visible light Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus The measurement of forearm blood flow will be use to assess endothelial function The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None