Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism.

Conditions: 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care.
MedDRA version: 9.1Level: LLTClassification code 10021067Term: Hypopituitarism
MedDRA version: 9.1Level: LLTClassification code 10033662Term: Panhypopituitarism
MedDRA version: 9.1Level: LLTClassification code 10056438Term: Growth hormone deficiency
MedDRA version: 9.1Level: LLTClassification code 10011318Term: Craniopharyngioma
MedDRA version: 9.1Level: LLTClassification code 10061538Term: Pituitary tumour benign
MedDRA version: 9.1Level: LLTClassification code 10036832Term: Prolactinoma
MedDRA version: 9.1Level: LLTClassification code 10011651Term: Cushing's disease
MedDRA version: 9.1Level: LLTClassification code 10035104Term: Pituitary tumour

Registration Number: EUCTR2009-010918-30-IE

Lead Sponsor: Amar Agha, Beaumont Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

Inclusion Criteria

1.Age 18 and over
2.Hypopituitary including GHD and ACTH deficiency previously diagnosed on dynamic stimulation testing
3.Underlying diagnosis including non functioning pituitary adenoma, prolactin secreting pituitary adenoma, craniopharyngioma, treated Cushing’s disease (with permanent ACTH/cortisol deficiency
4.Stable dose of GH and hydrocortisone replacement for at least 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with liver or kidney disease as this affects cortisol metabolism and measurements
2.Females of childbearing potential
3.Terminal or severe acute medical illness
4.Patients receiving steroids for reasons other than pituitary hormone replacement
5.Patients with malignancy, chronic inflammatory conditions or chronic infections