Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:08 PM
Study NCT ID:
NCT00711061
Status:
COMPLETED
Last Update Posted:
2009-02-10
First Post:
2008-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-09', 'studyFirstSubmitDate': '2008-07-03', 'studyFirstSubmitQcDate': '2008-07-07', 'lastUpdatePostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare carotid artery intima medial thickness', 'timeFrame': 'During study visit'}], 'secondaryOutcomes': [{'measure': 'Compare metabolic parameters and body composition measurements', 'timeFrame': 'During study visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the cardiovascular risks of growth hormone deficient young adult males who have completed growth hormone therapy to healthy young adult males.', 'detailedDescription': 'Adults with growth hormone deficiency are at risk for cardiovascular disease. What age this begins is not known.\n\nThe objectives of this study are to compare the following measurements between growth hormone deficient young males 3-7 years post completion of growth hormone treatment and age related healthy controls:\n\n1. Carotid artery imaging\n2. Metabolic and cardiac parameters\n3. Body composition measurements'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Endocrine clinic and community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Growth Hormone Deficient Inclusion Criteria:\n\n* Males, 18-25 years old\n* Completed growth hormone therapy approximately 3-5 years prior to study enrollment\n* History of multiple pituitary hormone deficiencies or growth hormone stimulation test \\<7 at initiation of growth hormone therapy\n\nHealthy Control Inclusion Criteria:\n\n* Males, 18-25 years old\n* No confirmed endocrine diagnosis including Diabetes and thyroid disorders\n* BMI - z-score within 2 SD of mean\n\nExclusion Criteria:\n\n* Known risk factors for cardiovascular disease (eg tobacco use, hypertension, diabetes)\n* Family history of early cardiovascular disease (myocardial infarction or stroke \\<55years of age) in first degree family members\n* Any implanted device\n* Medication known to interfere with glucose or lipid metabolism or to influence blood pressure\n* Chronic organ illness (eg severe asthma, hepatic or nephritic conditions)'}, 'identificationModule': {'nctId': 'NCT00711061', 'briefTitle': 'Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy.', 'orgStudyIdInfo': {'id': '07-07-119E'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '18-25 year old males, growth hormone deficient, who completed growth hormone treatment 3-5 years prior to enrollment in study'}, {'label': '2', 'description': '18-25 year old males, healthy, never treated with growth hormones.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Childrens Mercy Hospitals and Clinics', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Carol Huseman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Carol Huseman, MD', 'oldOrganization': "Children's Mercy Hospital"}}}}