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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00720902 |
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Date of registration:
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16/06/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Adult Growth Hormone Deficiency and Cardiovascular Risk
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Scientific title:
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Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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8 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00720902 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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John C Ausiello, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults 19 years or older who have undergone transsphenoidal surgery for a clinically
non-secreting pituitary adenoma
Exclusion Criteria:
- 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
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Growth hormone releasing hormone (GHRH) and arginine
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Procedure: Endothelial cell biopsy
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Procedure: Blood draws
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Procedure: MRI
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Procedure: Carotid ultrasound
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Primary Outcome(s)
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Serum cardiovascular risk markers including lipids, CRP, IL-6 and homocysteine
[Time Frame: once]
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Secondary Outcome(s)
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Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy
[Time Frame: once]
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Intramyocellular and intrahepatic lipid content using MRI and MR spectroscopy
[Time Frame: once]
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Insulin sensitivity as assessed by fasting insulin and glucose levels and by an oral glucose tolerance test
[Time Frame: once]
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Percentage of total body fat, trunk fat and lean body mass by DEXA
[Time Frame: once]
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Carotid intimal-medial thickness studies as assessed by ultrasound
[Time Frame: once]
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Secondary ID(s)
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AAAB9681 (Serono-001)
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Serono-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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