The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons
- Conditions
- Interaction Between the GH/IGF-I System and the Immune-system
- Interventions
- Registration Number
- NCT00969644
- Lead Sponsor
- Herlev Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- Healthy, normal blood tests
- Previous cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pegvisomant Pegvisomant - GH Somatropin -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Endocrinology J 106, Herlev Hospital
🇩🇰Herlev, Denmark