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

NCT ID: NCT00969644

Last Updated: 2009-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GH

Group Type ACTIVE_COMPARATOR

Somatropin

Intervention Type DRUG

s.c injections once daily 10-30 mícrogram/kg/day

Pegvisomant

Group Type ACTIVE_COMPARATOR

Pegvisomant

Intervention Type DRUG

s.c. injections once daily (10-15 mg/day)

Interventions

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Somatropin

s.c injections once daily 10-30 mícrogram/kg/day

Intervention Type DRUG

Pegvisomant

s.c. injections once daily (10-15 mg/day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, normal blood tests

Exclusion Criteria

* Previous cancer
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Endocrinology, Herlev Hospital, 2730 Herlev Ringvej 75, Herlev

Locations

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Department of Endocrinology J 106, Herlev Hospital

Herlev, Herlev, Denmark

Site Status

Countries

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Denmark

References

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Andreassen M, Frystyk J, Faber J, Kristensen LO, Juul A. Growth hormone (GH) activity is associated with increased serum oestradiol and reduced anti-Mullerian 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.

Reference Type DERIVED
PMID: 23785020 (View on PubMed)

Other Identifiers

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HC-2009-049

Identifier Type: -

Identifier Source: org_study_id

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