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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

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ClinicalTrials.gov Identifier: NCT00969644
Recruitment Status : Unknown
Verified August 2009 by Herlev Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : September 1, 2009
Last Update Posted : September 1, 2009
Sponsor:
Information provided by:
Herlev Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Interaction Between the GH/IGF-I System and the Immune-system Drug: Somatropin Drug: Pegvisomant Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : September 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: GH Drug: Somatropin
s.c injections once daily 10-30 mícrogram/kg/day
Active Comparator: Pegvisomant Drug: Pegvisomant
s.c. injections once daily (10-15 mg/day)



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   22 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, normal blood tests

Exclusion Criteria:

  • Previous cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969644


Locations
Denmark
Department of Endocrinology J 106, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mikkel Andreassen, MD., Department of Endocrinology, Herlev Hospital, 2730 Herlev Ringvej 75, Herlev
ClinicalTrials.gov Identifier: NCT00969644     History of Changes
Other Study ID Numbers: HC-2009-049
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: September 1, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Hormones
Mitogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action