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

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Christie NHS Foundation Trust
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Over 18 years of age

• Confirmed severe AGHD

• GH response <9 mU/l (preferably <4) to insulin-induced hypoglycaemia or glucagon stimulation test plus (These tests will have taken place as part of routine management).

• Full, stable pituitary replacement therapy

• Willing to provide informed consent

Exclusion Criteria:

• Unwilling to provide written consent

• Current GH therapy

• Pharmacological doses of glucocorticoids

• Any acute illness