Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00720902
Status:
TERMINATED
Last Update Posted:
2022-11-16
First Post:
2008-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adult Growth Hormone Deficiency and Cardiovascular Risk
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': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013007', 'term': 'Growth Hormone-Releasing Hormone'}, {'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, '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': 'GH Sufficient Participants', 'description': 'Participants with a history of pituitary disease, but who have a history of being GH sufficient.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GH Deficient Participants', 'description': 'Participants with a history of pituitary disease who have a history of being GH deficient', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C-reactive Protein (CRP) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '14.46', 'spread': '14.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'C-reactive protein (CRP) levels in GH sufficient and GH deficient participants', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'PRIMARY', 'title': 'Homocysteine Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '8.04', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Homocytsteine levels in GH sufficient and GH deficient participants', 'unitOfMeasure': 'micromol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'PRIMARY', 'title': 'Total Cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '271', 'spread': '90.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Total cholesterol levels in GH sufficient and GH deficient participants', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Fat Measured by DXA DEXA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'title': 'Total body fat', 'categories': [{'measurements': [{'value': '42.33333333', 'spread': '8.73', 'groupId': 'OG001'}]}]}, {'title': 'Trunk fat', 'categories': [{'measurements': [{'value': '21', 'spread': '3.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Percentage of total body fat and trunk fat as measured by DXA', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'SECONDARY', 'title': 'Lean Body Mass by DXA DEXA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '46.67', 'spread': '2.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Lean body mass as measured by DXA', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'SECONDARY', 'title': 'Insulin Sensitivity as Assessed by Fasting Insulin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '28.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Insulin sensitivity as assessed by fasting insulin levels', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'SECONDARY', 'title': 'Glucose Levels as Assessed by an Oral Glucose Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '91.33', 'spread': '4.163', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Glucose levels as assessed by an oral glucose tolerance test', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'SECONDARY', 'title': 'Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'timeFrame': 'Day 1', 'description': 'Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of participants as sufficient or deficient could not be performed and the remainder of the tests could not be done. As a result, data were not collected for GH sufficient or GH deficient participants for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'timeFrame': 'Year 1', 'description': 'Carotid intimal-medial thickness studies will be measured by ultrasound', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of participants as sufficient or deficient could not be performed and the remainder of the tests could not be done. As a result, data were not collected for GH sufficient and GH deficient participants.'}, {'type': 'SECONDARY', 'title': 'Intramyocellular Lipid Content Using MRI and MR Spectroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '0.011763', 'spread': '0.00159', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.', 'unitOfMeasure': 'Percent water signal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}, {'type': 'SECONDARY', 'title': 'Intrahepatic Lipid Content Using MRI and MR Spectroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion'}, {'id': 'OG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '9.97', 'spread': '7.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.', 'unitOfMeasure': 'Percent water signal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Growth Hormone (GH) Sufficient Participants', 'description': 'Participants with normal growth hormone secretion.'}, {'id': 'FG001', 'title': 'Growth Hormone (GH) Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to perform testing, lack of test agent and the Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GH Sufficient Participants', 'description': 'Participants with normal growth hormone secretion.'}, {'id': 'BG001', 'title': 'GH Deficient Participants', 'description': 'Participants with growth hormone secretion deficiency.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2008-06-16', 'resultsFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2008-07-22', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-24', 'studyFirstPostDateStruct': {'date': '2008-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-reactive Protein (CRP) Levels', 'timeFrame': 'Day 1', 'description': 'C-reactive protein (CRP) levels in GH sufficient and GH deficient participants'}, {'measure': 'Homocysteine Level', 'timeFrame': 'Day 1', 'description': 'Homocytsteine levels in GH sufficient and GH deficient participants'}, {'measure': 'Total Cholesterol Level', 'timeFrame': 'Day 1', 'description': 'Total cholesterol levels in GH sufficient and GH deficient participants'}], 'secondaryOutcomes': [{'measure': 'Percentage of Fat Measured by DXA DEXA', 'timeFrame': 'Day 1', 'description': 'Percentage of total body fat and trunk fat as measured by DXA'}, {'measure': 'Lean Body Mass by DXA DEXA', 'timeFrame': 'Day 1', 'description': 'Lean body mass as measured by DXA'}, {'measure': 'Insulin Sensitivity as Assessed by Fasting Insulin Levels', 'timeFrame': 'Day 1', 'description': 'Insulin sensitivity as assessed by fasting insulin levels'}, {'measure': 'Glucose Levels as Assessed by an Oral Glucose Tolerance Test', 'timeFrame': 'Day 1', 'description': 'Glucose levels as assessed by an oral glucose tolerance test'}, {'measure': 'Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy', 'timeFrame': 'Day 1', 'description': 'Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.'}, {'measure': 'Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound', 'timeFrame': 'Year 1', 'description': 'Carotid intimal-medial thickness studies will be measured by ultrasound'}, {'measure': 'Intramyocellular Lipid Content Using MRI and MR Spectroscopy', 'timeFrame': 'Day 1', 'description': 'Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.'}, {'measure': 'Intrahepatic Lipid Content Using MRI and MR Spectroscopy', 'timeFrame': 'Day 1', 'description': 'Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Growth hormone'], 'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.', 'detailedDescription': 'Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma\n\nExclusion Criteria:\n\n* Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of \\> 30 mg/day, pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT00720902', 'briefTitle': 'Adult Growth Hormone Deficiency and Cardiovascular Risk', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas', 'orgStudyIdInfo': {'id': 'AAAB9681 (Serono-001)'}, 'secondaryIdInfos': [{'id': 'Serono-001', 'type': 'OTHER', 'domain': 'protocol'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A - Normal growth hormone secretion', 'description': 'Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \\& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.', 'interventionNames': ['Procedure: Blood draws', 'Drug: growth hormone releasing hormone (GHRH) & arginine', 'Procedure: Carotid ultrasound', 'Procedure: MRI', 'Procedure: Endothelial cell biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B - Growth hormone deficient', 'description': 'Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \\& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.', 'interventionNames': ['Procedure: Blood draws', 'Drug: growth hormone releasing hormone (GHRH) & arginine', 'Procedure: Carotid ultrasound', 'Procedure: MRI', 'Procedure: Endothelial cell biopsy']}], 'interventions': [{'name': 'Blood draws', 'type': 'PROCEDURE', 'description': 'Subjects will have serum cardiovascular markers assessed', 'armGroupLabels': ['A - Normal growth hormone secretion', 'B - Growth hormone deficient']}, {'name': 'growth hormone releasing hormone (GHRH) & arginine', 'type': 'DRUG', 'description': 'Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.', 'armGroupLabels': ['A - Normal growth hormone secretion', 'B - Growth hormone deficient']}, {'name': 'Carotid ultrasound', 'type': 'PROCEDURE', 'description': 'Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.', 'armGroupLabels': ['A - Normal growth hormone secretion', 'B - Growth hormone deficient']}, {'name': 'MRI', 'type': 'PROCEDURE', 'description': 'Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.', 'armGroupLabels': ['A - Normal growth hormone secretion', 'B - Growth hormone deficient']}, {'name': 'Endothelial cell biopsy', 'type': 'PROCEDURE', 'description': 'Subjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed.', 'armGroupLabels': ['A - Normal growth hormone secretion', 'B - Growth hormone deficient']}]}, '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': 'John C Ausiello, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Pamela U. Freda', 'investigatorAffiliation': 'Columbia University'}}}}