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Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I might have anti-inflammatory effects. To elucidate this hypothesis the investigators have planned a study to investigate if 3 weeks administration of GH and subsequently the GH antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory markers in healthy volunteers.
To investigate if administration of 3 weeks og GH (10-30 microgram/kg/day) and subsequent Pegvisomant (10-15 mg/day) influence serum concentrations of the inflammatory variables Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and the newly discovered acute phase protein YKL-40. The study involves 12 healthy volunteers age from 22-65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GH | Active Comparator |
| |
| Pegvisomant | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | s.c injections once daily 10-30 mÃcrogram/kg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between changes in serum levels of Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and YKL-40 vs. changes in serum levels og IGF-I | 1/9 2009 - 1/3 2010 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology J 106, Herlev Hospital | Herlev | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23785020 | Derived | Andreassen M, Frystyk J, Faber J, Kristensen LO, Juul A. Growth hormone (GH) activity is associated with increased serum oestradiol and reduced anti-Mullerian hormone in healthy male volunteers treated with GH and a GH antagonist. Andrology. 2013 Jul;1(4):595-601. doi: 10.1111/j.2047-2927.2013.00096.x. |
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| Pegvisomant |
| Drug |
s.c. injections once daily (10-15 mg/day) |
|
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| C406545 | pegvisomant |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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