Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT01161394
Status:
COMPLETED
Last Update Posted:
2022-01-27
First Post:
2010-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2010-07-12', 'studyFirstSubmitQcDate': '2010-07-12', 'lastUpdatePostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammation', 'timeFrame': '12 weeks', 'description': 'Percent change in NFkb at baseline and after 1, 2, 4, 6, and 12 weeks of pioglitazone therapy.'}], 'secondaryOutcomes': [{'measure': 'inflammation', 'timeFrame': '12 weeks', 'description': 'TBARS (Thiobarbituric acid reactive substances), ortho and meta-tyrosine, 9-HODE and 13-HODE (hydroxyoctadecadieonic acid derivatives), Cellular/nuclear fractions and DNA binding activity of Nuclear Factor kb, Ikb (inhibitory kappa B), TNF-a(Tumor necrosis factor a), ICAM-1 (Intracellular adhesion molecule 1), VCAM-1(Vascular adhesion molecule 1), PAI-1 (Plasminogen Activator Inhibitor -1) and CRP (C-Reactive protein) and %change in vascular reactivity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'Pioglitazone decreases oxidative load, inflammatory end points and improves vascular reactivity in obese patients in a dose dependent manner and that this effect is independent of its glucose lowering effects.', 'detailedDescription': 'This is a single center, open labeled study. A total of 24 obese patients will be recruited to participate in this study. The study will have three groups of 8 patients each. Subjects will be enrolled into each group by alternate recruitment. Subjects in group one will receive 15mg of pioglitazone; subjects in group two will receive 30 mg of pioglitazone; subjects in group three will receive placebo. All subjects will receive Pioglitazone or placebo for 6 weeks, followed by a 6-week observation period off Pioglitazone/placebo.\n\nAt baseline, and at week 1, week 2, week 4, week 6 and month 3 all patients will have blood drawn for TBARS, ortho and meta-tyrosine, 9-HODE and 13-HODE, NF, Ikb, TNF-a, ICAM-1, VCAM-1, PAI-1, AP-1, EGR-1, MMP-2, MMP-9, TIMP, CRP-1, E-Selectin, P-Selectin, Asymmetric dimethylarginine (ADMA), PAPP-A, SAA, MCP-1, IL-6, ROS generation, insulin levels, and CRP.\n\nPost-ischemic dilation of the brachial artery will be used as an index of endothelium-mediated vasodilation. All subjects will have an oral glucose tolerance test (GTT) with 75gm of glucose at Day 0 and at Day 42. Vascular reactivity will be assessed at 0, 6, and at 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Obese (BMI\\>=30)\n\n * Age: 20 to 65 years of age inclusive\n * Without established clinical coronary artery disease (documented history or myocardial infarction, typical angina and an exercise ECG positive for ischemia or angiographic evidence of CAD)\n * Good health as evidence by History and Physical exam\n * Female subjects must be:\n\nPostmenopausal for at least one year or Surgically incapable of childbearing (i.e. have had a hysterectomy or tubal ligation) or, if capable of childbearing a subject, must be practicing an acceptable method of contraception.\n\n• Subject will be available for duration of the study and willing to comply with all study requirements.\n\nExclusion Criteria:\n\n* • Diabetes Mellitus\n\n * Allergy or sensitivity to Pioglitazone\n * Current use of Insulin therapy.\n * Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks\n * Hepatic disease (transaminase \\> 3 times normal)\n * Renal impairment (Creatinine clearance \\< 50 mL/min)\n * History of drug or alcohol abuse\n * COPD\n * Participation in any other concurrent clinical trial\n * Any other life-threatening, non-cardiac disease\n * Use of an investigational agent or therapeutic regimen within 30 days of study\n * Pregnancy or nursing'}, 'identificationModule': {'nctId': 'NCT01161394', 'briefTitle': 'Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study', 'orgStudyIdInfo': {'id': '1851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone 15mg', 'description': '8 patient will receive this drug', 'interventionNames': ['Drug: Pioglitazone 15mg']}, {'type': 'EXPERIMENTAL', 'label': 'pioglitazone 30mg', 'description': '8 patients will get this drug', 'interventionNames': ['Drug: pioglitazone 30mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '8 patient will get this drug', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Pioglitazone 15mg', 'type': 'DRUG', 'armGroupLabels': ['Pioglitazone 15mg']}, {'name': 'pioglitazone 30mg', 'type': 'DRUG', 'armGroupLabels': ['pioglitazone 30mg']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14226', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Millard Fillmore gates Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Paresh Dandona, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaleida Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda Pharmaceuticals North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Paresh Dandona', 'investigatorAffiliation': 'University at Buffalo'}}}}