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

Herlev Hospital

Status: Unknown

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

Treatments: Drug: Pegvisomant; Drug: Somatropin

Study type: Interventional

Funder types: Other

Identifiers

NCT00969644

HC-2009-049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, normal blood tests

Exclusion criteria

• Previous cancer

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

GH

Active Comparator group

Treatment:

Drug: Somatropin

Pegvisomant

Active Comparator group

Treatment:

Drug: Pegvisomant