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

H

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)

12 participants in 2 patient groups

GH
Active Comparator group
Treatment:
Drug: Somatropin
Pegvisomant
Active Comparator group
Treatment:
Drug: Pegvisomant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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