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

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

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00969644
• Other study ID #: HC-2009-049
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 31, 2009
• Last updated: August 31, 2009
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2009
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy, normal blood tests

Exclusion Criteria:

• Previous cancer

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Drug:
• Somatropin
s.c injections once daily 10-30 mícrogram/kg/day
• Pegvisomant
s.c. injections once daily (10-15 mg/day)

Locations

Country	Name	City	State
Denmark	Department of Endocrinology J 106, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relationship between changes in serum levels of Tumor Necrosis Factor a (TNF-a), 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	Yes