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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: |
NCT00929799 |
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Date of registration:
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29/06/2009 |
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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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Growth Hormone and Glucose Metabolism
GHGMS |
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Scientific title:
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Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00929799 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Ayman M Arafat, Dr.med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charite Campus Benjamin Franklin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients >18 years old.
- Severe GH deficiency as diagnosed by an inadequate GH stimulation in three different
tests:
1. peak response < 3 µg/l during an insulin tolerance test;
2. < 3 µg/l during glucagon test;
3. < 9 µg/l during GHRH-arginine stimulation test).
Exclusion Criteria:
- GH replacement therapy prior to inclusion.
- History of diabetes Type 1 or 2.
- Biochemical evidence of impaired hepatic or renal function.
- History of cardiovascular disease.
- Uncontrolled hypertension.
- Current inflammatory or malignant disease.
- Pregnancy.
Age minimum:
18 Years
Age maximum:
N/A
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: recombinant human Growth Hormone (Genotropin® )
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Primary Outcome(s)
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Change from baseline in insulin sensitivity after 24 and 48 weeks of treatment with low GH dose in severely GH deficient patients.
[Time Frame: At 24 and 48 weeks of treatment]
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Secondary Outcome(s)
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Changes from baseline in insulin secretion and insulin clearance, as well as changes in body composition, lipolysis, cardiovascular risk markers, Adiponectin, IMCL and 11ßHSD activity.
[Time Frame: At 24 and 48 weeks of treatment]
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Secondary ID(s)
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EK218-01
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NRA 6280012
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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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