Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Retina; Regional Blood Flow; Endotoxin, Escherichia Coli
Intervention: vitamin and mineral supplement (Drug); Escherichia coli Endotoxin (LPS) (Drug); 100% O2 (Drug); nitroglycerin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Michael Wolzt, MD, Principal Investigator, Affiliation: Department of Clinical Pharmacology, Medical University of Vienna
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.
Clinical Details
Official title: Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Retinal blood flow
Secondary outcome: Choroidal blood flowFlow mediated dilation (FMD) of brachial artery assessed with ultrasound Blood pressure, heart rate Body temperature Concentration of cytokines in plasma
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men aged between 18 and 35 years, nonsmokers
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination unless the
investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be
clinically irrelevant
- Normal ophthalmic findings, ametropia < 3 Dpt
Exclusion Criteria:
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical
trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as
well
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History of hypersensitivity to the trial drug or to drugs with a similar chemical
structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions
known to interfere with, distribution, metabolism or excretion of study drugs
- Blood donation during the previous 3 weeks
Locations and Contacts
Department of Clinical Pharmacology, Medical University of Vienna, Vienna 1090, Austria
Additional Information
Starting date: September 2006
Last updated: July 1, 2008
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