NCT00969644

The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Interaction Between the GH/IGF-I System and the Immune-system

Interventions

Type	Name	Description
DRUG	Somatropin	s.c injections once daily 10-30 mícrogram/kg/day
DRUG	Pegvisomant	s.c. injections once daily (10-15 mg/day)

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-09-01
• Last updated: 2009-09-01

Locations

1 site across 1 country: Denmark