Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-27 @ 7:19 AM
Study NCT ID:
NCT00708357
Status:
TERMINATED
Last Update Posted:
2014-11-17
First Post:
2008-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019323', 'term': 'omega-N-Methylarginine'}], 'ancestors': [{'id': 'D001120', 'term': 'Arginine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-14', 'studyFirstSubmitDate': '2008-06-26', 'studyFirstSubmitQcDate': '2008-06-30', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genotyping', 'timeFrame': 'performed during the first year before measurements'}]}, 'conditionsModule': {'keywords': ['eNOS Gene Polymorphism', 'ocular blood flow'], 'conditions': ['Ocular Physiology', 'Regional Blood Flow']}, 'descriptionModule': {'briefSummary': '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.\n\nIn the present study the investigators want to investigate if the T -786C eNOS gene polymorphism determines choroidal and optic nerve head blood flow.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged between 19 and 35 years, nonsmokers\n* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant\n* Homozygous variants of the T -786C genotyping (CC or TT)\n* Normal ophthalmic findings, ametropia less than 3 diopters\n\nExclusion Criteria:\n\n* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study\n* Treatment in the previous 3 weeks with any drug\n* Symptoms of a clinically relevant illness in the 3 weeks before the first study day\n* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure\n* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs\n* Blood donation during the previous 3 weeks'}, 'identificationModule': {'nctId': 'NCT00708357', 'briefTitle': 'Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?', 'orgStudyIdInfo': {'id': 'OPHT-311004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'homozygous mutant: CC allele of the eNOS T-786C gene', 'interventionNames': ['Drug: NG-monomethyl-L-arginine']}, {'type': 'OTHER', 'label': '2', 'description': 'homozygous mutant: TT allele of the eNOS T-786C gene', 'interventionNames': ['Drug: NG-monomethyl-L-arginine']}], 'interventions': [{'name': 'NG-monomethyl-L-arginine', 'type': 'DRUG', 'otherNames': ['L-NMMA'], 'description': 'intravenous administration, bolus over 5 minutes, dosage 6mg/kg', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of Clinical Pharmacology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Wolzt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of CLinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof Priv.-Doz. Dr', 'investigatorFullName': 'Gerhard Garhofer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}