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Effect of Pegvisomant on GH/IGF-I Relationship in GHD

NCT00468624 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL

Last updated 2007-05-03

No results posted yet for this study

Summary

Approximately 50% of middle-aged patients with severe AGHD have a normal age-related serum IGF-I. It remains unclear if in these individuals serum IGF-I is GH dependent or independent. This study compared the relationship between GH and serum IGF-I in two cohorts of male patients with severe AGHD; one with normal and the other with subnormal age-related serum IGF-I values. The GH receptor antagonist - pegvisomant was be used to specifically inhibit GH action and the changes in markers of the GH axis, such as serum IGF-I, IGFBP-3, GH and GHBP were measured.

Conditions

  • Severe Adult Growth Hormone Deficiency

Interventions

DRUG

pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks

PROCEDURE

GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo)

PROCEDURE

blood sampling before and after pegvisomant/placebo

PROCEDURE

arginine stimulation test after each limb

Sponsors & Collaborators

  • The Christie NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Peter J Trainer, MD FRCP · Christie Hospital NHS

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Completion
2005-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00468624 on ClinicalTrials.gov