Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 5:50 AM
Study NCT ID:
NCT01101204
Status:
UNKNOWN
Last Update Posted:
2012-07-09
First Post:
2010-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-05', 'studyFirstSubmitDate': '2010-04-07', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiinflammatory effects of combined antidiabetic and hypolipemic treatment', 'timeFrame': '30 days', 'description': 'As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines:\n\n1. Interleukin 1\n2. TNF alpha\n3. Interleukin 6\n4. Interleukin 10\n5. hsCRP'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': '30 days', 'description': 'Assesed by HOMA (Homeostatic Model of Assessment)'}, {'measure': 'Coagulation parameters', 'timeFrame': '30 days', 'description': 'Assessed using:\n\n1. Fibrinogen\n2. PAI-1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Dyslipidemia', 'Inflammation', 'Cytokines']}, 'descriptionModule': {'briefSummary': 'The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (35-64yr)\n* Primary hyperlipidemia (Total cholesterol \\>200mg/dl, Triglycerides \\>150mg/dl)\n* Type 2 Diabetes\n* For women:\n* Menopause (\\>12 months)\n* Post hysterectomy\n* Mechanical contraception\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Secondary hyperlipidemia\n* Morbid obesity (BMI\\>40kg/m2)\n* Alcohol or drug abuse\n* Acute or chronic inflammation\n* Congestive Heart Failure (NYHA III or IV)\n* Unstable Ischaemic Heart Disease\n* Moderate or severe hypertension\n* Cancer in less than 5 years\n* Chronic kidney disease (stage III-V)\n* Liver failure\n* Oral contraception\n* Not compliant patient\n* Laboratory results:\n* alanine transferase (\\>3xULN)\n* creatine kinase (\\>5xULN)\n* haemoglobin (\\<10/dl)\n* PLT (\\<100G/l)\n* WBC (\\<3,5G/l or \\>10G/l)'}, 'identificationModule': {'nctId': 'NCT01101204', 'acronym': 'MSF', 'briefTitle': 'The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': "Effects of High and Low Doses of Metformin, Fenofibrate and Simvastatin, Administered Together and in Sequence With Lifestyle Intervention on Lipid Profile, Glucose Metabolism, Low-grade Inflammation and Hemostasis in Patient's Blood Plasma in Type 2 Diabetic Patients With Serious Mixed Dyslipidemia", 'orgStudyIdInfo': {'id': 'MSF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'M1000 S10 F100', 'description': 'metformin 1000mg, fenofibrate 100mg and simvastatin 10mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'M1000 S10 F267', 'description': 'metformin 1000mg, fenofibrate 267mg and simvastatin 10mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'M1000 S40 F100', 'description': 'metformin 1000mg, fenofibrate 100mg and simvastatin 40mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'M1000 S40 F267', 'description': 'metformin 1000mg, fenofibrate 267mg and simvastatin 40mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'M2500 S10 F100', 'description': 'metformin 2500mg, fenofibrate 100mg and simvastatin 10mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'M2500 S10 F267', 'description': 'metformin 2500mg, fenofibrate 267mg and simvastatin 10mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'M2500 S40 F267', 'description': 'metformin 2500mg, fenofibrate 267mg and simvastatin 40mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'M2500 S40 F100', 'description': 'metformin 2500mg, fenofibrate 100mg and simvastatin 40mg', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Therapeutic Lifestyle Change', 'description': 'Only therapeutic lifestyle change', 'interventionNames': ['Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg']}], 'interventions': [{'name': 'Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg', 'type': 'DRUG', 'description': 'Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.', 'armGroupLabels': ['M1000 S10 F100', 'M1000 S10 F267', 'M1000 S40 F100', 'M1000 S40 F267', 'M2500 S10 F100', 'M2500 S10 F267', 'M2500 S40 F100', 'M2500 S40 F267', 'Therapeutic Lifestyle Change']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40752', 'city': 'Katowice', 'state': 'Katowice', 'country': 'Poland', 'contacts': [{'name': 'Krzysztof Labuzek, MD, PhD', 'role': 'CONTACT', 'email': 'lbuldak@gmail.com', 'phone': '+48 32 252 39 02'}, {'name': 'Łukasz Bułdak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bogusław Okopień, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Krzysztof Labuzek, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Clinical Pharmacology', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'centralContacts': [{'name': 'Krzysztof Labuzek, MD, PhD', 'role': 'CONTACT', 'email': 'lbuldak@gmail.com', 'phone': '+48 32 252 39 02'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Bogusław Okopień', 'investigatorAffiliation': 'Medical University of Silesia'}}}}