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

NCT00851942 | Completed Phase 4

• 1 other identifier: SPON 431-07
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Adrenal Insufficiency; Hypopituitarism

Keywords

Volunteer; Hypoadrenalism; Hypopituitarism; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• The primary end-point of the study will be to establish method dependent cortisol cut offs for the normal response to Synacthen® using the 5th percentile.

  Cortisol response at 30 minutes

Secondary Outcomes (4)

• Cortisol measurements by immunoassay will be compared with the GC-MS gold standard method for normal volunteers and patients with hypopituitarism and hypoadrenalism.

  Cortisol response at 30 minutes

• Synacthen® responses in women taking ethinyloestradiol-containing contraceptive pills will be compared with those who are not.

  Cortisol response at 30 minutes

• We will establish cut offs for the salivary cortisol response to Synacthen® in normal volunteers using the 5th percentile.

  Cortisol response at 30 minutes

• We will establish a 17OHP cut off in response to Synacthen® in normal female volunteers using the 5th percentile.

  17OHP response at 60 minutes

Study Arms (1)

Synacthen 250 micrograms

EXPERIMENTAL

IV injection of 250 micrograms of Synacthen in 1m

Drug: Synacthen (Tetracosactrin)

Interventions

Synacthen (Tetracosactrin) DRUG

IV injection of 250 micrograms of Synacthen in 1ml

Also known as: Synacthen

Synacthen 250 micrograms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiff University: lead

Study Sites (1)

Clinical Research Facility, University Hospital of Wales

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Owen LJ, Adaway JE, Davies S, Neale S, El-Farhan N, Ducroq D, Evans C, Rees DA, MacKenzie F, Keevil BG. Development of a rapid assay for the analysis of serum cortisol and its implementation into a routine service laboratory. Ann Clin Biochem. 2013 Jul;50(Pt 4):345-52. doi: 10.1177/0004563212473448. Epub 2013 Jun 12.

  PMID: 23761380 DERIVED

MeSH Terms

Conditions

Adrenal Insufficiency; Hypopituitarism

Interventions

Cosyntropin; adrenocorticotropin zinc

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenocorticotropic Hormone; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Aled Rees, MB BCh, PhD

  Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: September 1, 2008
• Primary Completion: July 28, 2012
• Study Completion: January 31, 2013
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

GB (1)