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

NCT ID: NCT00708357

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ocular Physiology Regional Blood Flow

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

homozygous mutant: CC allele of the eNOS T-786C gene

Group Type OTHER

NG-monomethyl-L-arginine

Intervention Type DRUG

intravenous administration, bolus over 5 minutes, dosage 6mg/kg

2

homozygous mutant: TT allele of the eNOS T-786C gene

Group Type OTHER

NG-monomethyl-L-arginine

Intervention Type DRUG

intravenous administration, bolus over 5 minutes, dosage 6mg/kg

Interventions

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NG-monomethyl-L-arginine

intravenous administration, bolus over 5 minutes, dosage 6mg/kg

Intervention Type DRUG

Other Intervention Names

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L-NMMA

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc Prof Priv.-Doz. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Wolzt, MD

Role: PRINCIPAL_INVESTIGATOR

Department of CLinical Pharmacology

Locations

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Department of Clinical Pharmacology

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-311004

Identifier Type: -

Identifier Source: org_study_id