We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708357
Recruitment Status : Terminated
First Posted : July 2, 2008
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:

Nitric oxide (NO) is a potent endothelium-derived vasodilatator that plays a major role in the control of ocular blood flow. Endothelial NO synthase (eNOS) is one of three isoforms of NOS producing NO through hydroxylation of L-arginine. The eNOS gene is located on the long arm of chromosome 7, and different polymorphic variations have been identified. These single nucleotide polymorphisms (sNP´s) have the ability to change transcription activity and therefore enzyme levels. Recent data indicate that the T -786C polymorphism (especially the homozygous variant) is associated with reduced eNOS activity and consequently impaired NO production.

In the present study the investigators want to investigate if the T -786C eNOS gene polymorphism determines choroidal and optic nerve head blood flow.


Condition or disease Intervention/treatment Phase
Ocular Physiology Regional Blood Flow Drug: NG-monomethyl-L-arginine Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?
Study Start Date : May 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
homozygous mutant: CC allele of the eNOS T-786C gene
Drug: NG-monomethyl-L-arginine
intravenous administration, bolus over 5 minutes, dosage 6mg/kg
Other Name: L-NMMA

2
homozygous mutant: TT allele of the eNOS T-786C gene
Drug: NG-monomethyl-L-arginine
intravenous administration, bolus over 5 minutes, dosage 6mg/kg
Other Name: L-NMMA




Primary Outcome Measures :
  1. Genotyping [ Time Frame: performed during the first year before measurements ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged between 19 and 35 years, nonsmokers
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Homozygous variants of the T -786C genotyping (CC or TT)
  • Normal ophthalmic findings, ametropia less than 3 diopters

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708357


Locations
Layout table for location information
Austria
Department of Clinical Pharmacology
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Michael Wolzt, MD Department of CLinical Pharmacology
Layout table for additonal information
Responsible Party: Gerhard Garhofer, Assoc Prof Priv.-Doz. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00708357    
Other Study ID Numbers: OPHT-311004
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Keywords provided by Gerhard Garhofer, Medical University of Vienna:
eNOS Gene Polymorphism
ocular blood flow
Additional relevant MeSH terms:
Layout table for MeSH terms
omega-N-Methylarginine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action