Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-27 @ 9:51 PM
Study NCT ID:
NCT01799850
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2012-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Actos Treatment of Diabetes on Glucose Transporters in Muscle
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': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000073893', 'term': 'Sugars'}], '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'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-25', 'studyFirstSubmitDate': '2012-03-20', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in muscle glucose transporter expression', 'timeFrame': 'post eight weeks treatment', 'description': 'immunoblots pre and post, placebo and Actos'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['muscle', 'glucose transporters', 'GLUT4', 'GLUT5', 'Actos'], 'conditions': ['Diabetes Type 2']}, 'referencesModule': {'references': [{'pmid': '17251278', 'type': 'RESULT', 'citation': 'Stuart CA, Howell ME, Yin D. Overexpression of GLUT5 in diabetic muscle is reversed by pioglitazone. Diabetes Care. 2007 Apr;30(4):925-31. doi: 10.2337/dc06-1788. Epub 2007 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'Subjects with type 2 diabetes will be treated with Actos or placebo for eight weeks and needle biopsies of muscle will quantify changes in any of seven different glucose transport proteins in muscle.', 'detailedDescription': 'Twelve subjects with type 2 diabetes, with fair control on oral medication, will be recruited to participate in a randomized, double-blind, placebo-controlled study of the impact on muscle glucose transporter expression of the addition of the insulin-sensitizing agent, pioglitizone (Takeda Pharmaceuticals). Therapy with the active drug will be at 30 mg daily. The other oral medications will be adjusted downward if hypoglycemia occurs. Glycemic control will be monitored by at least twice daily home blood glucose monitoring, weekly telephone contacts, and follow-up visits to the ETSU/VAMC Clinical Research Unit (CRU) every two weeks. During the eight weeks of therapy, subjects will be instructed to maintain their weight and keep their dietary and exercise regimens unchanged. Muscle biopsies will be obtained before and at the end of eight weeks of therapy. Specimens will be assayed for GLUT1, GLUT3, GLUT4, GLUT5, GLUT8, GLUT11, and GLUT12 mRNA and protein content and the subcellular distribution of these proteins as described below. Peroxisome proliferator-activated receptor gamma (PPARgamma), a member of the ligand-activated nuclear hormone receptor superfamily (14), will be quantified in these specimens by immunoblot as described below.\n\nThis study design involving a randomized, double-blinded, placebo-controlled treatment regimen is needed to control for confounding variables causing changes in glucose transporter expression that may be erroneously attributed to the drug. These potential variables include close contact with the diabetes management team resulting in improved compliance with diet, exercise, medication, and monitoring and thus better glycemic control, weight loss, or improved fitness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes, type 2\n* HbA1c less than 8.5\n\nExclusion Criteria:\n\n* insulin therapy\n* renal insufficiency\n* clinically apparent coronary disease'}, 'identificationModule': {'nctId': 'NCT01799850', 'briefTitle': 'The Impact of Actos Treatment of Diabetes on Glucose Transporters in Muscle', 'organization': {'class': 'OTHER', 'fullName': 'East Tennessee State University'}, 'officialTitle': 'The Impact of Actos Treatment of Diabetes on Glucose Transporters in Muscle', 'orgStudyIdInfo': {'id': 'TPNA 02-037A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Actos', 'description': 'Actos 30 mg daily', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'double blind placebo controlled', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos or placebo'], 'description': 'pioglitazone 30 mg daily, pill, eight weeks, placebo randomly assigned', 'armGroupLabels': ['Actos']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'placebo assigned randomly, double blind', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37614', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'ETSU Quillen College of Medicine', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}], 'overallOfficials': [{'name': 'Charles A Stuart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETSU Quillen College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Tennessee State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda Pharmaceuticals North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Internal Medicine', 'investigatorFullName': 'Charles A. Stuart', 'investigatorAffiliation': 'East Tennessee State University'}}}}