Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-31 @ 9:27 AM
Study NCT ID:
NCT01466556
Status:
UNKNOWN
Last Update Posted:
2011-11-08
First Post:
2011-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Incidence of Metabolic Syndrome Among Obese Children in Our Region
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-07', 'studyFirstSubmitDate': '2011-11-03', 'studyFirstSubmitQcDate': '2011-11-07', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of children with metabolic syndrome', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the prevalence of metabolic syndrome amongst obese children in our region with a body mass index (BMI) above the 95th percentile for age and sex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children who visit our outpatient clinic or a routine visit to the ER', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with BMI over 95 percentile\n\nExclusion Criteria:\n\n* Obesity secondary to medication use\n* Obesity secondary to genetic disease'}, 'identificationModule': {'nctId': 'NCT01466556', 'briefTitle': 'The Incidence of Metabolic Syndrome Among Obese Children in Our Region', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '80-2010-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese children', 'interventionNames': ['Other: Routine laboratory tests']}], 'interventions': [{'name': 'Routine laboratory tests', 'type': 'OTHER', 'description': 'Laboratory tests to determine metabolic syndrome', 'armGroupLabels': ['Obese children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hadera', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Renata Yaakobov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Renata Yaacobov, MD', 'role': 'CONTACT', 'email': 'renatay@hy.health.gov.il', 'phone': '972-050-624-6969'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}