Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-20 @ 6:24 PM
Study NCT ID:
NCT00558935
Status:
TERMINATED
Last Update Posted:
2011-05-10
First Post:
2007-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'It was found that 20g of alcohol daily had no effect on ABCA1 expression or HDL levels.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-09', 'studyFirstSubmitDate': '2007-11-14', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurements of dyslipidemia', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'lipid functionality', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of red wine on ABCA1 levels'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* Aged 18-65 years\n* Free of overt coronary disease\n* BMI \\< 35\n* Fasting plasma glucose \\<6.1 mmol\n* Unmedicated\n* No major illness\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Smokers\n* Participants with alcoholism'}, 'identificationModule': {'nctId': 'NCT00558935', 'briefTitle': 'The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'orgStudyIdInfo': {'id': '24/06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Red Wine', 'type': 'DIETARY_SUPPLEMENT', 'description': '20g alcohol daily/red wine for 4 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Baker Heart Research Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Bronwyn A Kingwell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baker Heart Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}}}}