Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-27 @ 4:58 PM
Study NCT ID:
NCT01087632
Status:
COMPLETED
Last Update Posted:
2010-09-02
First Post:
2010-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Armolipid Plus and Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001599', 'term': 'Berberine'}, {'id': 'C117343', 'term': 'red yeast rice'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'C080710', 'term': 'policosanol'}, {'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'C005948', 'term': 'astaxanthine'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D001600', 'term': 'Berberine Alkaloids'}, {'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-01', 'studyFirstSubmitDate': '2010-03-12', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2010-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin/glucose ratio after overnight fast', 'timeFrame': '18 weeks', 'description': 'HOMA INDEX'}, {'measure': 'Insuline/glucose ratio after an oralglucose tolerance test', 'timeFrame': '18 weeks', 'description': 'OGTT'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '18 weeks', 'description': 'evaluation of weight and BMI'}, {'measure': 'Glycemia', 'timeFrame': '18 weeks', 'description': 'Blood Glucose'}, {'measure': 'Endothelial function', 'timeFrame': '18 weeks', 'description': 'endothelial function assessed by Flow Mediated Dilation'}, {'measure': 'C reactive protein.', 'timeFrame': '18 weeks', 'description': 'dosage of CRP'}, {'measure': 'Serum lipidemia', 'timeFrame': '18 weeks', 'description': 'measure of TG and cholesterol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome Insulin-resistance Endothelial Function'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues.\n\nArmolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on indices of insulin resistance.\n\nAim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on the diagnostic parameters of metabolic syndrome.\n\n60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).\n\nPrimary end point will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index) and after an oral glucose tolerance test (OGTT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference \\> 102 cm (M) or \\>88 cm(F), and two or more of these criteria:\n\n* fasting blood glucose \\>100 mg;\n* systolic blood pressure \\>135 or diastolic blood pressure \\>85 mmHg or patients in treatment with antihypertensive drugs;\n* triglyceridemia \\>150 mg/dl;\n* HDL cholesterolemia \\< 40 mg/dl(M), \\< 50 mg/dl(F).\n\nExclusion Criteria:\n\n* pregnancy\n* diabetes mellitus in pharmacologic treatment;\n* hepatic failure;\n* creatininemia \\>2 mg/dl;\n* triglyceridemia \\> 500 mg/dl;\n* heart failure.'}, 'identificationModule': {'nctId': 'NCT01087632', 'briefTitle': 'Armolipid Plus and Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rottapharm'}, 'officialTitle': 'Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'ARMP-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Armolipid Plus', 'description': 'Armolipid Plus is an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,- policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg', 'interventionNames': ['Dietary Supplement: Armolipid Plus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching Armolipid plus', 'interventionNames': ['Dietary Supplement: Armolipid Plus']}], 'interventions': [{'name': 'Armolipid Plus', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['berberine', 'red yeast rice', 'monacolin K', 'policosanol', 'coenzyme Q10', 'astaxanthin', 'folic acid'], 'description': 'Armolipid Plus 1 tablet QD for 18 weeks', 'armGroupLabels': ['Armolipid Plus', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Naples', 'state': 'Naples', 'country': 'Italy', 'facility': 'Federico II University - Department of Internal Medicine', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Serafino Fazio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rottapharm', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Federico II University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': "Massimo D'Amato, MD", 'oldOrganization': 'Rottapharm'}}}}