Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-04-07 @ 5:09 PM
Study NCT ID:
NCT00854503
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2009-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'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': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-11', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose tolerance assessed by HbA1c and fasting glucose', 'timeFrame': '1, 6, 12 months'}], 'secondaryOutcomes': [{'measure': 'insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.', 'timeFrame': '1, 6, 12 months.'}]}, 'conditionsModule': {'keywords': ['Statins administration in diabetic dyslipidemia'], 'conditions': ['Type 2 Diabetes', 'Diabetic Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes in good glycemic control, treated with metformin alone.\n* Untreated dyslipidemia.\n* BMI \\<30.\n\nExclusion Criteria:\n\n* History of cancer.\n* History of cardiovascular diseases.\n* Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.'}, 'identificationModule': {'nctId': 'NCT00854503', 'briefTitle': 'Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'orgStudyIdInfo': {'id': '131/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin', 'description': 'Simvastatin 20 mg/day', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'description': 'Rosuvastatin 20 mg/day', 'interventionNames': ['Drug: Rosuvastatin']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'description': '20 mg/day in one oral administration', 'armGroupLabels': ['Simvastatin']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': '20 mg/day in one oral administration.', 'armGroupLabels': ['Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Rome', 'country': 'Italy', 'facility': 'University of Rome Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Davide Lauro', 'oldOrganization': 'University of Rome Tor Vergata'}}}}