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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: |
NCT00684957 |
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Date of registration:
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23/05/2008 |
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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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Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors
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Scientific title:
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Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00684957 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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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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Pamela U. Freda, M.D. |
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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:
- 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.
Exclusion Criteria:
- Female gender
- current GH use or GH use within three months of the study
- diabetes
- hypoglycemia
- liver or kidney disease
- use of drugs that could increase GH secretion (i.e. L-dopa)
- alcohol or substance abuse
- use of investigational drugs within four weeks of our study and use of
supraphysiologic doses of steroids within the previous six months.
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Male
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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: Recombinant human IGF-1
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Drug: Recombinant Human Growth Hormone
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Primary Outcome(s)
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Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine
[Time Frame: 2 months]
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Secondary Outcome(s)
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Changes in visceral adiposity, intrahepatic and intramyocellular lipids
[Time Frame: 2 months]
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Changes in endothelial cell function
[Time Frame: 2 months]
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Secondary ID(s)
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Tercica-001
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AAAC2883
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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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