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

Tracking Information
First Received Date ^ICMJE	August 31, 2009
Last Updated Date	August 31, 2009
Start Date ^ICMJE	September 2009
Estimated Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons
Official Title ^ICMJE	The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons
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.
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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Interaction Between the GH/IGF-I System and the Immune-system
Intervention ^ICMJE	Drug: Somatropin s.c injections once daily 10-30 mícrogram/kg/day Drug: Pegvisomant s.c. injections once daily (10-15 mg/day)
Study Arm (s)	Active Comparator: GH Intervention: Drug: Somatropin Active Comparator: Pegvisomant Intervention: Drug: Pegvisomant
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	12
Estimated Completion Date	March 2010
Estimated Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy, normal blood tests Exclusion Criteria: Previous cancer
Gender	Both
Ages	22 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00969644
Other Study ID Numbers ^ICMJE	HC-2009-049
Has Data Monitoring Committee	Yes
Responsible Party	Mikkel Andreassen, MD., Department of Endocrinology, Herlev Hospital, 2730 Herlev Ringvej 75, Herlev
Study Sponsor ^ICMJE	Herlev Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Herlev Hospital
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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