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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: |
NCT00462475 |
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Date of registration:
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18/04/2007 |
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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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Effect of 5 Years of GH Replacement on Atherosclerosis
5yrGH |
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Scientific title:
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Phase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary Patients |
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Date of first enrolment:
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January 1996 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00462475 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Annamaria AL Colao, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University "Federico II" |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- male gender
- age <50 yrs to limit the effect of aging;
- body mass index <30 Kg/m2;
- no familial or personal history of cardiovascular diseases;
- no concomitant treatment with drugs known to interfere with glucose or lipid
metabolism or to influence blood pressure at the time of study entry;
- no previous GH treatment
Exclusion Criteria:
- female gender
- age >50 yrs;
- body mass index =30;
- familial or personal history of cardiovascular diseases;
- previous and present treatments with drugs known to interfere with glucose or lipid
metabolism or to influence blood pressure;
- previous GH treatment in adult age
- GHD of childhood onset
- GHD due to previous Cushing's disease
Age minimum:
18 Years
Age maximum:
50 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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Pituitary Tumors
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Hypopituitarism
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Intervention(s)
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Drug: Recombinant Growth Hormone, Genotropin (Pfizer)
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Primary Outcome(s)
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Intima-media thickness at common carotid arteries at baseline and after 5 years
[Time Frame: 5 yrs]
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Secondary Outcome(s)
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Prevalence of insulin resistance (IR) syndrome (IRS) and LDL/HDL-cholesterol ratio at baseline and after 5 years
[Time Frame: 5 yrs]
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Secondary ID(s)
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NeuroendoUnit-3
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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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