Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT00545857
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2007-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-30', 'studyFirstSubmitDate': '2007-10-16', 'studyFirstSubmitQcDate': '2007-10-16', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-peptide response to a Sustacal meal', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Insulin requirement', 'timeFrame': '6 months'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Insulin dependent diabetes', 'Juvenile onset diabetes', 'pioglitazone'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24379032', 'type': 'DERIVED', 'citation': 'Tafuri KS, Godil MA, Lane AH, Wilson TA. Effect of pioglitazone on the course of new-onset type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2013;5(4):236-9. doi: 10.4274/Jcrpe.981.'}]}, 'descriptionModule': {'briefSummary': 'A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.', 'detailedDescription': 'Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 diabetes mellitus diagnosed within 4 months\n* Age \\> 6 years of age\n* Ability to swallow capsule\n* Signed informed consent / assent\n\nExclusion Criteria:\n\n* Other illnesses'}, 'identificationModule': {'nctId': 'NCT00545857', 'briefTitle': 'Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '20064114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone', 'interventionNames': ['Drug: pioglitazone', 'Drug: Placebo control']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control', 'interventionNames': ['Drug: pioglitazone', 'Drug: Placebo control']}], 'interventions': [{'name': 'pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': 'Pioglitazone daily; dose varies with size', 'armGroupLabels': ['Pioglitazone', 'Placebo control']}, {'name': 'Placebo control', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': 'Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus', 'armGroupLabels': ['Pioglitazone', 'Placebo control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794-8111', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Thomas A. Wilson, MD', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Thomas A Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York Stony Brook'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Thomas A. Wilson', 'investigatorAffiliation': 'Stony Brook University'}}}}