Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-04 @ 8:44 AM
Study NCT ID:
NCT00493259
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2007-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2007-06-26', 'studyFirstSubmitQcDate': '2007-06-27', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health-Related Quality of Life'], 'conditions': ['Insulin Resistance', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.', 'detailedDescription': "Matched historical control study designed to examine outcomes on insulin resistant adolescents who were treated in the Insulin Resistance Syndrome Clinic at Children's Mercy Hospital in the past year. New patients will be screened at baseline, 4 and 12 months to evaluate if there is improvement in the BMI Z-score, HgA1c, lipid profile or waist circumference when depression and/or altered health related quality of life are identified and treated in this population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 11-17 years of age who are seen in the Insulin Resistance Clinic for the first time\n* Historical control: Patients 11-19 years of age seen in the Insulin Resistance Clinic during the prior four months\n\nExclusion Criteria:\n\n* Co-morbid syndrome (Downs, Turner's, Prader Willi etc)\n* Diagnosis of Type 2 Diabetes\n* Taking Metformin before the initial visit\n* Taking medication for or diagnosis of a psychiatric condition prior to initial visit\n* Developmentally delayed"}, 'identificationModule': {'nctId': 'NCT00493259', 'briefTitle': 'Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Health-related Quality of Life, Depression and the Impact on Successful Incorporation of Lifestyle Changes in Insulin Resistant Adolescents as Evidenced by Changes in BMI, Waist Circumference and Metabolic Parameters', 'orgStudyIdInfo': {'id': '07 02-037E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Health-Related Quality of Life instrument', 'type': 'BEHAVIORAL', 'description': 'Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome'}, {'name': 'Depression Scale for Children (CES-DC)', 'type': 'BEHAVIORAL', 'description': 'questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Adrienne Platt, MS, CPNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}