Mean Values of Oxidative Stress Parameters in Healthy Subjects

NCT ID: NCT00313118

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Healthy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratory Dr. Bayer GmbH, Stuttgart, Germany

UNKNOWN

Sponsor Role: collaborator

Selim Orguel

OTHER

Sponsor Role: lead

Responsible Party

Selim Orguel

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Selim Orgül, MD

Role: STUDY_DIRECTOR

University Hospital, Basel, Switzerland

Locations

University Eye Clinic Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

067-KOA-2005-001

Identifier Type: -

Identifier Source: org_study_id