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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Herlev Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969644
First Posted: September 1, 2009
Last Update Posted: September 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Herlev Hospital
  Purpose
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 Intervention
Interaction Between the GH/IGF-I System and the Immune-system Drug: Somatropin Drug: Pegvisomant

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: September 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: August 31, 2009
First Posted: September 1, 2009
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