Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-29 @ 3:29 PM
Study NCT ID:
NCT01819402
Status:
UNKNOWN
Last Update Posted:
2013-03-27
First Post:
2013-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pioglitazone Decreases Visceral Fat Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-24', 'studyFirstSubmitDate': '2013-03-24', 'studyFirstSubmitQcDate': '2013-03-24', 'lastUpdatePostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'All cardiovascular events and all cause death for 5 years', 'timeFrame': 'Baseline and 5 years after treatment'}], 'primaryOutcomes': [{'measure': 'Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging.', 'timeFrame': 'Baseline and 16 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers', 'timeFrame': 'Baseline and 16 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['visceral fat metabolism; FDG-PET/CT; pioglitazone; glimepiride; adiponectin'], 'conditions': ['To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging']}, 'descriptionModule': {'briefSummary': 'Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between the ages of 35 and 85 years\n* Subjects with impaired glucose tolerance and type 2 diabetes\n\nExclusion Criteria:\n\n* Subjects with insulin treatment\n* Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease\n* Subjects taking more than three antidiabetic medications\n* Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization\n* Subjects with cardiac failure (New York Heart Association Class \\> III) or left ventricular dysfunction (LVEF \\< 40%)\n* Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease'}, 'identificationModule': {'nctId': 'NCT01819402', 'briefTitle': 'Pioglitazone Decreases Visceral Fat Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Kurume University'}, 'officialTitle': 'Effects of Pioglitazone on Visceral Fat Metabolic Activity', 'orgStudyIdInfo': {'id': 'PIO FAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: 1', 'description': 'up to 30 mg pioglitazone, tablet, orally, once daily', 'interventionNames': ['Drug: Pioglitazone vs Glimepiride']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Comparator: 1', 'description': 'up to 4 mg/day glimepiride, tablet, orally, once daily', 'interventionNames': ['Drug: Pioglitazone vs Glimepiride']}], 'interventions': [{'name': 'Pioglitazone vs Glimepiride', 'type': 'DRUG', 'armGroupLabels': ['Active Comparator: 1', 'Sham Comparator: 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '830-0011', 'city': 'Kurume', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Nobuhiro Tahara, MD, PhD', 'role': 'CONTACT', 'email': 'ntahara@med.kurume-u.ac.jp', 'phone': '+81-942-31-7580'}], 'facility': 'Kurume University', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}], 'centralContacts': [{'name': 'Nobuhiro Tahara, MD, PhD', 'role': 'CONTACT', 'email': 'ntahara@med.kurume-u.ac.jp', 'phone': '+81-942-31-7580'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kurume University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Nobuhiro Tahara', 'investigatorAffiliation': 'Kurume University'}}}}