Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-03-01 @ 8:30 AM
Study NCT ID:
NCT03931434
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2019-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double Blind Placebo Controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2019-04-29', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.', 'timeFrame': '12 months', 'description': 'Progression rates of low attenuation plaque under influence of Aged Garlic Extract (AGE) as compared to placebo.'}], 'secondaryOutcomes': [{'measure': 'Rate of change in inflammatory biomarkers (CRP,IL-6)', 'timeFrame': '12 months', 'description': 'Rate of change in inflammatory biomarkers'}, {'measure': 'Rate of change in endothelial function', 'timeFrame': '3 months and 12 months', 'description': 'Endothelial Function and arterial stiffness measured by cardio-ankle vascular index (CAVI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'Endothelium'], 'conditions': ['Coronary Arteriosclerosis', 'Endothelial Dysfunction', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to see the effect of taking Aged Garlic Extract (AGE) on the progression of coronary plaque, a condition called atherosclerosis, in people diagnosed with Diabetes.', 'detailedDescription': 'This clinical trial is to determine on progression rates of low attenuation plaque under influence of Aged Garlic Extract as compared to placebo over the 1year period in individuals with Type 2 Diabetes Mellitus.The study also examines the effect of Aged Garlic Extract on endothelial function and arterial stiffness which was measured by cardio-ankle vascular index (CAVI) over the 3months period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 30-75 years\n* Known Diabetes Mellitus (HgA1c \\>6.5%, fasting blood sugar \\>125 mg/dl, taking anti- diabetes medications)\n* Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them\n* Calcium Score \\>20 at baseline\n\nExclusion Criteria:\n\n* A contraindication to AGE including: known hypersensitivity to drug.\n* Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study\n* Weight in excess of 350 pounds\n* Bleeding disorder\n* History of known coronary artery disease, myocardial infarction, stroke or life- threatening arrhythmia within the prior six months\n* NYHA Class II- IV heart failure\n* History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy\n* Serum creatinine \\> 1.4 mg/dl\n* Triglycerides \\> 400 at visit 1\n* Drug or alcohol abuse, or current intake of more than 14 standard drinks per week\n* Concurrent enrollment in another placebo-controlled trial\n* Partial ileal bypass or known gastrointestinal disease limiting drug absorption\n* Current tobacco use\n* Current use of anticoagulants (except for anti-platelet agents)\n* Renal failure\n* History of hypertensive encephalopathy or cerebrovascular accident\n* Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT03931434', 'briefTitle': 'Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}, 'officialTitle': 'Effect of Aged Garlic Extract (AGE) on Progression of Coronary Atherosclerosis in Persons With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Garlic-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aged Garlic Extract (AGE)', 'description': '2400mg of Aged Garlic Extract (AGE)', 'interventionNames': ['Dietary Supplement: Aged Garlic Extract (AGE)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The Placebo does not contain any Aged Garlic Extract (AGE)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Aged Garlic Extract (AGE)', 'type': 'DIETARY_SUPPLEMENT', 'description': '2400mg of Aged Garlic Extract (AGE)', 'armGroupLabels': ['Aged Garlic Extract (AGE)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matthew J. Budoff', 'investigatorAffiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}}}}