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

Early Phase 1

Terminated

• Conditions: Ocular Physiology; Regional Blood Flow
• Interventions: Drug: NG-monomethyl-L-arginine

• Registration Number: NCT00708357
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-02
• Primary Completion: 2009-12
• Study Completion: 2013-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	NG-monomethyl-L-arginine	homozygous mutant: CC allele of the eNOS T-786C gene
2	NG-monomethyl-L-arginine	homozygous mutant: TT allele of the eNOS T-786C gene

Primary Outcome Measures

Name	Time	Method
Genotyping	performed during the first year before measurements

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria