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

Regional Blood Flow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00708357
• Other study ID #: OPHT-311004
• Status: Terminated
• Phase: Phase 0
• First received: June 26, 2008
• Last updated: November 14, 2014
• Start date: May 2005
• Est. completion date: January 2013

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ocular Physiology
• Regional Blood Flow

Intervention

Drug:
• NG-monomethyl-L-arginine
intravenous administration, bolus over 5 minutes, dosage 6mg/kg

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotyping		performed during the first year before measurements	No