Salivary Cortisone as an Adrenal Insufficiency Test in Children
Research type
Research Study
Full title
A prospective feasibility study of awakening salivary glucocorticoids to exclude adrenal insufficiency in the paediatric population
IRAS ID
272812
Contact name
Charlotte Elder
Contact email
Sponsor organisation
Sheffield Children's NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
Adrenal insufficiency (AI) describes the body’s failure to produce adequate cortisol (stress hormone). Low cortisol levels lead to fatigue, muscle weakness, low blood glucose levels and low blood pressure. Failure of cortisol production in times of stress, e.g. surgery, infection or trauma can result in serious illness or death. AI has many different causes but the commonest in children is receiving steroids for inflammatory conditions such as arthritis. The most popular diagnostic test for AI is the Short Synacthen Test (SST), which investigates the ability of the adrenal glands to produce cortisol. The SST requires a daycase hospital admission for Synacthen (a drug that stimulates the adrenal glands to produce cortisol) to be given by injection and blood samples collected before and after to assess the cortisol response to Synacthen. It is therefore invasive, time-consuming and resource-intensive. Researchers have been looking for a screening test to help reduce the number of SSTs we perform. Blood cortisol has been used but studies have shown it is not accurate enough, meaning many SST are being performed on children with normal adrenal function.
Cortisol is converted to cortisone in the salivary glands. Our study will examine whether a salivary cortisone sample performed at home, soon after awakening, is a more accurate, patient-friendly, convenient and cheaper screening test for AI. If it is then many patients won’t need to come to hospital for a blood test or SST. The study will involve children who are already coming to the hospital for an SST collecting a saliva sample soon after they first wake up to start their day. They will then come to hospital for their SST and we can compare the salivary cortisone levels with blood cortisol levels taken during the SST to see if it would make a reliable and accurate screening test.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
19/YH/0402
Date of REC Opinion
8 Jan 2020
REC opinion
Further Information Favourable Opinion