Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide
Research type
Research Study
Full title
Salivary and Serum Glucocorticoid Reproducibility Study (STARLIT-1)
IRAS ID
318183
Contact name
Keith Pugh
Contact email
Sponsor organisation
Sheffield Children's NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Research Summary
The adrenal glands sit above the kidneys and are part of the body's endocrine system. They produce cortisol, an essential hormone which is released as part of the body's stress response and helps to control blood pressure and blood sugar levels. Adrenal insufficiency (AI) describes the inability of the body to produce adequate levels of cortisol which, without treatment with replacement cortisol, can lead to serious illness and death. The Short Synacthen Test (SST) is the most popular diagnostic test for AI worldwide. Synacthen is a drug structurally very similar to the brain hormone, adrenocorticotropic hormone (ACTH), which stimulates the adrenal glands to produce cortisol. The SST requires intravenous cannulation and blood sampling before and after the Synacthen is given. It is thus invasive, resource-intensive (requiring a day care hospital admission and trained staff to deliver the test) and unpleasant for the patient, especially children. A non-invasive, needle-free alternative to the SST has been developed, with Synacthen given nasally via a spray and the resultant adrenal response measured by the rise in salivary cortisone (the salivary equivalent to cortisol). The STARLIT-1 study is looking to determine the reliability of salivary cortisone sampling. This will be done by measuring three paired (taken at the same time) samples of blood cortisol and salivary cortisol and cortisone over five minutes in healthy volunteers. Results will be analysed to see if there is significant variation between the samples. The less variation, the more reliable the test.
Summary of Results
The Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide (STARLIT-1) study was a small repeatability study carried out by a research team led by Dr Charlotte Elder at Sheffield Children’s Hospital. The Sponsor for the study was Sheffield Children’s Hospital NHS Foundation Trust, and the study was funded by the Medical Research Council (MRC).
The research team have previously developed a new test for diagnosing adrenal insufficiency (the inability of the body’s adrenal glands to produce enough of the vital stress hormone, cortisol). The Short Synacthen Test (SST) is currently the most popular diagnostic test worldwide, but it is invasive, resource-intensive, and often unpleasant for the patients, as it involves intravenous cannulation and blood sampling. The team therefore sought to develop a non-invasive, needle-free alternative, in which the Synacthen drug is given via a nasal spray, and the resultant response is measured in saliva samples.
The STARLIT-1 study looked to determine the reliability of measuring levels of salivary cortisone (the salivary equivalent to cortisol) in saliva samples. The main aim of the study was to see if there was significant variation between repeated salivary cortisone samples collected from the same individual. The less variation, the more reliable the measurement.
Thirteen healthy volunteers were recruited to the study, and each attended a single study visit at the Clinical Research Facility at Sheffield Children’s Hospital. Each participant provided three paired (taken at the same time) samples of blood (serum) and saliva over 5 minutes. Samples were analysed by a third-party commercial laboratory to quantify the levels of blood cortisol and salivary cortisol and cortisone in the samples.
The results showed that there was no significant variation between repeated salivary cortisone measurements in the same person, and that the pattern of salivary cortisone results showed a close match to the serum cortisol results. Together, these results indicate that the salivary cortisone sampling is a reliable measurement of adrenal response when compared to serum cortisol used in the current standard test.
The results of this study enable the researchers to move on to start two key clinical studies (STARLIT-2 and STARLIT-3) which are due to be completed by July 2025. These are looking to see if the new test gives comparable results to the standard test in healthy volunteers and in patients with adrenal insufficiency.
To learn more about this, and related STARLIT studies, please visit the study website at https://hhtu.hull.ac.uk/starlit/
REC name
West of Scotland REC 1
REC reference
22/WS/0155
Date of REC Opinion
13 Dec 2022
REC opinion
Further Information Favourable Opinion