Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-02-01 @ 1:55 AM
Study NCT ID:
NCT00864461
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Metabolic Syndrome in Down Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo.', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods.', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Down syndrome', 'Metabolic syndrome X', 'Insulin resistance'], 'conditions': ['Metabolic Syndrome X', 'Down Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Down syndrome\n\nExclusion Criteria:\n\n* History of congenital cardiac defects requiring open-heart surgery\n* History of gastroenterologic anomalies requiring bowel resection and/or ongoing medical intervention\n* History of leukemia or other cancer\n* History of hypothyroidism requiring thyroid hormone replacement'}, 'identificationModule': {'nctId': 'NCT00864461', 'briefTitle': 'Frequency of Metabolic Syndrome in Down Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Guanajuato'}, 'officialTitle': 'Prevalence of Metabolic Syndrome in Down Syndrome Patients', 'orgStudyIdInfo': {'id': '249-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Patients with clinical and cytogenetics diagnosis of Down syndrome, between 7 - 24 years old.'}, {'label': 'Control', 'description': 'Siblings of the same gender of the case, between 7-24 years old.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37320', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'School of Medicine, University of Guanajuato', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Guanajuato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'ALEJANDRO ERNESTO MACIAS HERNANDEZ', 'investigatorAffiliation': 'Universidad de Guanajuato'}}}}