Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement

Conditions: 10 male patients with hypopituitarism resulting in ACTH (adrenocorticotropin) deficiency (ICD E23.0) will be studied on varying doses of hydrocortisone replacement therapy. THis is not a new medication for these patients.10 healthy male volunteers will be studied as control subjects. They will NOT receive hydrocortisone.
MedDRA version: 9.1Level: LLTClassification code 10021067Term: Hypopituitarism
MedDRA version: 9.1Level: LLTClassification code 10033662Term: Panhypopituitarism
MedDRA version: 9.1Level: LLTClassification code 10057217Term: Isolated ACTH deficiency

Registration Number: EUCTR2007-005018-37-IE

Lead Sponsor: Amar Agha

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 20

Inclusion Criteria

Male,
Age >18 years
Hypopituitarism
Known severe ACTH deficiency as defined by a basal serum cortisol <100nmol/l and failure of a stimulation test.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Female
Age <18 years
Patients with acute medical or surgical illness
Advanced cardiac or pulmonary disease
Unstable Angina/MI in the preceeding 3 months
Patients with a terminal illness
Patients on steroids for reasons other than ACTH deficiency
Patients on phenytoin or other agents that interfere with corticosteroid metabolism.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We aim to define the most appropriate physiological dose of glucocorticoid replacement in ACTH deficienct hypopituitary patients by studying different commonly used dose regimes of hydrocortisone replacement. The regimes range from 10mg to 30mg daily and we will assess the integrated serum cortisol levels, tissue cortisol exposure, metabolic and vascular sequelae of each regimen. We seek that whic most closely resembles the metabolic profile of our healthy control subjects.;Secondary Objective: To assess the side effects of over or under replacement of hydrocortisone in the hypopituitary patient.;Primary end point(s): The identification of a dose of hydrocortisone which results in a metabolic profile that most closely resembles that of the healthy control subjects.

Secondary Outcome Measures