Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-05 @ 5:52 AM
Study NCT ID:
NCT00684957
Status:
TERMINATED
Last Update Posted:
2024-07-17
First Post:
2008-05-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'puf1@columbia.edu', 'phone': '212-305-3725', 'title': 'Pamela Freda, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1', 'description': 'Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks.\n\nrhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)\n\nrhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone', 'description': 'Subjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks.\n\nrhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)\n\nrhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Subjects', 'description': 'Includes all subjects enrolled into the study.'}], 'timeFrame': '2 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Levels of cardiovascular serum risk markers were not measured and thus not analyzed due to poor enrollment.'}, {'type': 'SECONDARY', 'title': 'Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Subjects', 'description': 'Includes all subjects enrolled into the study.'}], 'timeFrame': '2 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Visceral adiposity, intrahepatic and intramyocllular lipids were not measured/collected and thus not analyzed due to poor enrollment.'}, {'type': 'SECONDARY', 'title': 'Changes in Endothelial Cell Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Subjects', 'description': 'Includes all subjects enrolled into the study.'}], 'timeFrame': '2 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Endothelial cell function was not measured/collected and thus not analyzed due to poor enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1', 'description': 'Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks.\n\nrhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)\n\nrhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)'}, {'id': 'FG001', 'title': 'Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone', 'description': 'Subjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks.\n\nrhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)\n\nrhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Subjects', 'description': 'Includes all subjects enrolled into the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2008-05-23', 'resultsFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2008-05-27', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-21', 'studyFirstPostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids', 'timeFrame': '2 months'}, {'measure': 'Changes in Endothelial Cell Function', 'timeFrame': '2 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rhGH', 'rhIGF-1'], 'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.', 'detailedDescription': 'Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that growth hormone (GH) and IGF-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass.\n\nExclusion Criteria:\n\n* Female gender\n* current GH use or GH use within three months of the study\n* diabetes\n* hypoglycemia\n* liver or kidney disease\n* use of drugs that could increase GH secretion (i.e. L-dopa)\n* alcohol or substance abuse\n* use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.'}, 'identificationModule': {'nctId': 'NCT00684957', 'briefTitle': 'Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency', 'orgStudyIdInfo': {'id': 'AAAC2883'}, 'secondaryIdInfos': [{'id': 'Tercica-001', 'type': 'OTHER', 'domain': 'Tercica'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant Human Growth Hormone first', 'description': 'Subjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks.', 'interventionNames': ['Drug: Recombinant Human Growth Hormone', 'Drug: Recombinant Human IGF-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant Human IGF-1', 'description': 'Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.', 'interventionNames': ['Drug: Recombinant Human Growth Hormone', 'Drug: Recombinant Human IGF-1']}], 'interventions': [{'name': 'Recombinant Human Growth Hormone', 'type': 'DRUG', 'otherNames': ['rhGH'], 'description': '300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)', 'armGroupLabels': ['Recombinant Human Growth Hormone first', 'Recombinant Human IGF-1']}, {'name': 'Recombinant Human IGF-1', 'type': 'DRUG', 'otherNames': ['rhIGF-1'], 'description': '30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)', 'armGroupLabels': ['Recombinant Human Growth Hormone first', 'Recombinant Human IGF-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University, College of Physicians and Surgeons', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pamela U. Freda, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tercica', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Endocrinology', 'investigatorFullName': 'Pamela U. Freda', 'investigatorAffiliation': 'Columbia University'}}}}