Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-06 @ 10:47 AM
Study NCT ID:
NCT00561132
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2007-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034028', 'term': 'vanadyl sulfate'}, {'id': 'D008277', 'term': 'Magnesium Oxide'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-19', 'studyFirstSubmitDate': '2007-11-19', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes on metabolic profile', 'timeFrame': '4 weeks'}, {'measure': 'Changes on anthropometrical measures', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vanadium', 'insulin sensitivity', 'impaired glucose tolerance', 'triglycerides'], 'conditions': ['Prediabetic State']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate if the vanadium can improve the insulin sensitivity in patients with impaired glucose tolerance. Secondary purpose of this study was to assess changes on metabolic profile, weight and blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of impaired glucose tolerance\n* Body mass index from 25 to 35 kg/m2\n* History of type 2 diabetes mellitus in the first branch\n\nExclusion Criteria:\n\n* Taking medication with known effects on carbohydrate or insulin metabolism\n* Thyroid diseases\n* Hepatic diseases'}, 'identificationModule': {'nctId': 'NCT00561132', 'briefTitle': 'Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Unidad de Investigacion Medica en Epidemiologia Clinica'}, 'officialTitle': 'Effect of Vanadium on Insulin Sensitivity in Patients With Impaired Glucose Tolerance', 'orgStudyIdInfo': {'id': '2002/252/129'}, 'secondaryIdInfos': [{'id': '173/03/13'}, {'id': 'FP-2003/073'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: Vanadyl sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Other: Magnesium oxide']}], 'interventions': [{'name': 'Vanadyl sulfate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vanadyl sulphate', 'Vanadyl sulfate hydrate', 'Vanadyl sulphate hydrate'], 'description': '50 mg twice daily orally for a period of 4 weeks', 'armGroupLabels': ['1']}, {'name': 'Magnesium oxide', 'type': 'OTHER', 'otherNames': ['Calcinated magnesia', 'Calcined Magnesite', 'Magnesia'], 'description': 'Validation of similar appearance and weight to the intervention component orally 1 unit (\\<50 mg) twice daily for a period of 4 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44320', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Unidad de Investigacion Medica en Epidemiologia Clinica, Hospital de Especialidades, UMAE, Centro Medico Nacional de Occidente', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Omar Jacques-Camarena, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidad de Investigacion Medica en Epidemiologia Clinica'}, {'name': 'Manuel González-Ortiz, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidad de Investigacion Medica en Epidemiologia Clinica'}, {'name': 'Esperanza Martínez-Abundis, MD, MSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unidad de Investigacion Medica en Epidemiologia Clinica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unidad de Investigacion Medica en Epidemiologia Clinica', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondo para el Fomento a la Investigacion Medica', 'class': 'UNKNOWN'}, {'name': 'Doctorado en Farmacologia de la Universidad de Guadalajara', 'class': 'UNKNOWN'}]}}}