Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test

• Status: Completed
• Trial end date: 2013-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

To establish valid serum total cortisol and salivary cut-offs for use with the short Synacthen test in patients with normal CBG concentrations.

To investigate, using current assays, the effect of assay differences on the serum total cortisol cut-off.

To explore the performance of these cut-offs in groups of patients with suspected adrenal insufficiency and high and low serum CBG concentration.

Methodology: An ACTH test (250 micrograms iv ACTH1-24) will be undertaken in healthy volunteers, women taking an oestrogen-containing oral contraceptive pill (OCP), patients with adrenal insufficiency and patients with low serum albumin. Serum cortisol in the samples collected from healthy volunteers will be measured using GC-MS, Advia Centaur (Siemens), Architect (Abbott), Modular Analytics E170 (Roche), Immulite 2000 (Siemens) and Access (Beckman) automated immunoassays. The estimated lower reference limit for the 30 min cortisol response to ACTH, defined as the 2.5th percentile of log-transformed concentrations, will be determined in this healthy population and used as a cut-off in the patient groups studied.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cardiff University
• Treatments: Cosyntropin; Hormones; Hydrocortisone

Criteria

Inclusion Criteria:

• Volunteers will be in self-proclaimed good health

• Volunteers will be free of illness on the day of testing

• Volunteers will not be taking drug therapy.

• Patients will be free of intercurrent illness on the day of testing

• Patients will have a confirmed diagnosis of hypoadrenalism or hypopituitarism

Exclusion Criteria:

• Is pregnant or lactating. Females of childbearing potential must have a negative pregnancy test before enrollment onto the study. Non-child bearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,

• Is using corticosteroids,

• has any significant intercurrent disease,

• has a history of thyroid or other autoimmune disease,

• has a previous history of hypersensitivity to Synacthen®,

• has a previous history of asthma

• has a history of allergic disorder

• has any mental condition rendering the patient unable to understand the nature or possible consequences of the study, and/or evidence of an uncooperative attitude.