Interaction Between the GH/IGF-I System and the Immune-system
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSomatropin
s.c injections once daily 10-30 mícrogram/kg/day
DRUGPegvisomant
s.c. injections once daily (10-15 mg/day)
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, normal blood tests
Exclusion criteria
* Previous cancer
Design outcomes
Primary
| Measure | 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 |
Countries
Denmark
Outcome results
None listed