Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
Study NCT ID:
NCT03943459
Status:
UNKNOWN
Last Update Posted:
2019-10-04
First Post:
2019-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011794', 'term': 'Quercetin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sirtuin-1', 'timeFrame': '60 days', 'description': 'serum concentration of sirtuin-1'}, {'measure': 'Soluble receptor for advanced glycation end products', 'timeFrame': '60 days', 'description': 'serum concentration of soluble receptor for advanced glycation end products'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'sirtuins', 'Receptor for Advanced Glycation End Products', 'women', 'quercetin', 'atorvastatin'], 'conditions': ['Coronary Artery Disease Progression']}, 'descriptionModule': {'briefSummary': 'Higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with coronary disease by reducing serum LDL-cholesterol. Therefore, a number of metabolic pathways are responsible for vascular health. The serum concentration and gene expression of sirtuin 1 (Sirt1) and RAGE soluble (sRAGE) are directly associated with vascular protection. This study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of Sirt1 and sRAGE in postmenopausal women with stable coronary artery disease.', 'detailedDescription': 'Higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with coronary artery disease (CAD) by reducing serum LDL-cholesterol. Therefore, a number of metabolic pathways are responsible for vascular health. The serum concentration and gene expression of sirtuin 1 (Sirt1) and RAGE soluble (sRAGE) are directly associated with vascular protection. This study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of Sirt1 and sRAGE in postmenopausal women with stable coronary artery disease and also the correlation between the changes in serum concentration of Sirt1 and sRAGE and the changes in lipid profile, inflammatory biomarkers and sex hormones in response to these drugs. This is a 60-day randomized, double blind, placebo-controlled study in 60 postmenopausal women with CAD, divided into three groups with 20 women each: Group 1 - Quercetin (500 mg / day); Group 2 - atorvastatin (80 mg / day): Group 3 - control.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postmenopausal women,\n* angiographic documented coronary artery disease,\n* stable coronary artery disease\n\nExclusion Criteria:\n\n* BMI \\<18,1 Kg/m2,\n* smoking,\n* hypo or hyperthyroidism,\n* rheumatic disease,\n* use of alcohol,\n* hepatic failure,\n* renal failure\n* hormone replacement therapy\n* use of insulin'}, 'identificationModule': {'nctId': 'NCT03943459', 'briefTitle': 'Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease', 'organization': {'class': 'OTHER', 'fullName': 'InCor Heart Institute'}, 'officialTitle': 'Serum Concentration and Gene Expression of Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Atherosclerotic Coronary Disease After Administration of Atorvastatin and Supplementation With Quercetin: Randomized Trial', 'orgStudyIdInfo': {'id': '408720/2018-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '20 Patients on placebo'}, {'type': 'NO_INTERVENTION', 'label': 'Atorvastatin', 'description': '20 patients treated with atorvastatin 80 mg/day'}, {'type': 'EXPERIMENTAL', 'label': 'Quercetin', 'description': '20 patients treated with quercetin 500 mg/day', 'interventionNames': ['Drug: Quercetin']}], 'interventions': [{'name': 'Quercetin', 'type': 'DRUG', 'otherNames': ['Atorvastatin'], 'description': 'Quercetin 250 mg BID', 'armGroupLabels': ['Quercetin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Antonio P Mansur, PhD', 'role': 'CONTACT', 'email': 'apmansur@usp.br', 'phone': '+551126615387'}, {'name': 'Antônio de Pádua Mansur, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José Rafael O Nascimento', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'INCOR - Heart Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Antonio P Mansur, PhD', 'role': 'CONTACT', 'email': 'apmansur@yahoo.com', 'phone': '+551126615387'}, {'name': 'José R Oliveira', 'role': 'CONTACT', 'email': 'jrafaelno@gmail.com', 'phone': '+551126615387'}], 'overallOfficials': [{'name': 'Antonio P Mansur, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'InCor Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InCor Heart Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'ANTONIO DE PADUA MANSUR', 'investigatorAffiliation': 'InCor Heart Institute'}}}}