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Mean Values of Oxidative Stress Parameters in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00313118
Recruitment Status : Withdrawn (Problems with recruiting)
First Posted : April 11, 2006
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Laboratory Dr. Bayer GmbH, Stuttgart, Germany
Information provided by (Responsible Party):
Selim Orguel, University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date April 10, 2006
First Posted Date April 11, 2006
Last Update Posted Date March 28, 2017
Study Start Date January 2006
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mean Values of Oxidative Stress Parameters in Healthy Subjects
Official Title Determination of the Mean Values of Oxidative Stress Parameters in the Plasma of Healthy Subjects
Brief Summary Determination of the mean value of oxidative stress parameters in normals and of the plasma and serum levels, resp. of malondialdehyde, glutathion and superoxide dismutase in healthy subjects.
Detailed Description

In certain situations, free radicals can be generated in an exaggerated manner and can injure tissues and organs by interacting with lipids, proteins, or DNA. So, oxidative stress has been implicated in a large number of human diseases. To survive, the human body has developed a complex, efficient, and highly adaptive antioxidant defense system. The eye is also protected against oxidative stress by several mechanisms involving antioxidant enzymes such as catalase (CAT) and superoxide dismutase (SOD), as well as by low-molecular-weight antioxidants such as glutathion (GSH) and ascorbate.

Primary open-angle glaucoma (POAG) is a chronic, slowly progressive optic neuropathy, characterized by excavation of the optic nerve head (ONH) and a distinctive pattern of visual field (VF) defects. The disease is multifactorial in origin, so that besides more extensively investigated factors oxidative stress has also been proposed as a contributing factor in the etiology of glaucomatous optic neuropathy. Oxidative stress represents a harmful state defined by the presence of pathologic levels of reactive oxygen species (ROS) relative to antioxidant defense.

Therefore, it would be also important to determine whether there is a relationship between circulating levels of the defense parameters to oxidative stress like malondialdehyde, GSH and SOD, and the occurrence of POAG.

Since there are only the limits of variation for these defense parameters available, mean values of the plasma levels of malondialdehyde, glutathion and superoxide dismutase will be determined in healthy subjects.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
plasma
Sampling Method Non-Probability Sample
Study Population healthy persons
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: March 27, 2017)
0
Original Enrollment
 (submitted: April 10, 2006)
40
Actual Study Completion Date December 2016
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • German native speakers
  • Age between 18-80 years
  • Healthy without medication
  • No ophthalmic disease

Exclusion Criteria:

  • Any history of ocular or systemic diseases or of drug or alcohol abuse
  • Any mentally impaired patient
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00313118
Other Study ID Numbers 067-KOA-2005-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Selim Orguel, University Hospital, Basel, Switzerland
Study Sponsor Selim Orguel
Collaborators Laboratory Dr. Bayer GmbH, Stuttgart, Germany
Investigators
Study Director: Selim Orgül, MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date March 2017