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

Sponsor
Medical University of Vienna (Other)
Overall Status
Terminated
CT.gov ID
NCT00708357
Collaborator
(none)
12
1
2
92.1
0.1

Study Details

Study Description

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
Early Phase 1

Study Design

Study Type:
Interventional
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 1, 2005
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • L-NMMA
  • Other: 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 Names:
  • L-NMMA
  • Outcome Measures

    Primary Outcome Measures

    1. Genotyping [performed during the first year before measurements]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Clinical Pharmacology Vienna Austria

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Michael Wolzt, MD, Department of CLinical Pharmacology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 2, 2008
    Last Update Posted:
    Nov 17, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Gerhard Garhofer, Assoc Prof Priv.-Doz. Dr, Medical University of Vienna
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2014