Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 4:28 AM
Study NCT ID:
NCT00522158
Status:
COMPLETED
Last Update Posted:
2007-08-29
First Post:
2007-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], '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': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-08-28', 'studyFirstSubmitDate': '2007-08-27', 'studyFirstSubmitQcDate': '2007-08-28', 'lastUpdatePostDateStruct': {'date': '2007-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-29', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Cardiovascular Disease', 'LDL Cholesterol', 'Cognition']}, 'descriptionModule': {'briefSummary': 'We aimed to compare the effect of achieving an LDL-cholesterol \\<70 vs an LDL-cholesterol \\<100 mg/dL with simvastatin or atorvastatin on adrenal and testicular steroidogenesis, and cognition in diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with controlled type 2 diabetes mellitus with overt CVD\n* patients with controlled type 2 diabetes mellitus over the age of 40 years without overt CVD,but with one or more major cardiovascular risk factors\n\nExclusion Criteria:\n\n* uncontrolled hypertension (systolic blood pressure \\>180 mm Hg or diastolic blood pressure \\>95 mm Hg); evidence of active active liver disease or hepatic dysfunction defined as a level of liver transaminases \\>2 times the upper limit of normal; uncontrolled myocardial ischaemia; congestive heart failure (New York Heart Association classification IIIb or IV); hemodynamically important valvular disease; secondary hypercholesterolemia; gastrointestinal disease that might limit drug absorption or partial ileal bypass; myopathy, or rhabdomyolysis; a known hypersensitivity to statins; using any androgenic, estrogenic, progestogenic, antiandrogenic, or antiestrogenic agents or medications that can alter the gonadal steroid milieu; using systemic immunosuppressants or anticoagulants; plasma creatine kinase levels \\>50% above the upper limit of normal,transient ischaemic attack or stroke in past,severe hypertriglyceridaemia (fasting triglyceride level ≥350 mg/dl,Currently on psychotropic medications, steroids, opiate analgesics, Known case of major neuropsychiatric illness,Poor cognition at baseline \\[Mini-Mental State Examination(MMSE) score ≤24\\],Physically or mentally unable to complete tests, history of other risk factors for hearing loss and/or conventional assessment that presented conductive hearing loss, confirmed by acoustic immittance measurement;presence of non-auditory associated disorders that could lead to long-latency potentials, such as neurological diseases or syndromes'}, 'identificationModule': {'nctId': 'NCT00522158', 'briefTitle': 'Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'orgStudyIdInfo': {'id': 'KA 05/75'}}, 'armsInterventionsModule': {'interventions': [{'name': 'simvastatin', 'type': 'DRUG'}, {'name': 'atorvastatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zehra Berberoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}}}}