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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00969644
First received: August 31, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 31, 2009
August 31, 2009
September 2009
March 2010   (final data collection date for primary outcome measure)
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 [ Time Frame: 1/9 2009 - 1/3 2010 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons
The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Interaction Between the GH/IGF-I System and the Immune-system
  • Drug: Somatropin
    s.c injections once daily 10-30 mícrogram/kg/day
  • Drug: Pegvisomant
    s.c. injections once daily (10-15 mg/day)
  • Active Comparator: GH
    Intervention: Drug: Somatropin
  • Active Comparator: Pegvisomant
    Intervention: Drug: Pegvisomant
Andreassen M, Frystyk J, Faber J, Kristensen LØ, Juul A. Growth hormone (GH) activity is associated with increased serum oestradiol and reduced anti-Müllerian hormone in healthy male volunteers treated with GH and a GH antagonist. Andrology. 2013 Jul;1(4):595-601. doi: 10.1111/j.2047-2927.2013.00096.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
12
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy, normal blood tests

Exclusion Criteria:

  • Previous cancer
Both
22 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00969644
HC-2009-049
Yes
Mikkel Andreassen, MD., Department of Endocrinology, Herlev Hospital, 2730 Herlev Ringvej 75, Herlev
Herlev Hospital
Not Provided
Not Provided
Herlev Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP