Status:
COMPLETED
Growth Hormone and Glucose Metabolism
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the study is to investigate changes in insulin sensitivity and ß-cell function after 24 and 48 weeks of low-dose growth hormone (GH) therapy in adult patients with severe GH deficiency usin...
Detailed Description
In adult patients with GH deficiency, it is well documented that treatment with recombinant human GH results in a reduction of visceral fat mass and an increase in muscle mass. During long-term treatm...
Eligibility Criteria
Inclusion
- Patients \>18 years old.
- Severe GH deficiency as diagnosed by an inadequate GH stimulation in three different tests:
- peak response \< 3 µg/l during an insulin tolerance test;
- \< 3 µg/l during glucagon test;
- \< 9 µg/l during GHRH-arginine stimulation test).
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00929799
Start Date
November 1 2003
End Date
August 1 2007
Last Update
June 30 2009
Active Locations (1)
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1
Charite Campus Benjamin Franklin
Berlin, Germany, 12200