A new breakthrough test offering a more convenient and less invasive way to diagnose adrenal insufficiency is to be pioneered in a clinical trial conducted by the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust.
Professor Richard Ross, Professor of Endocrinology at the University of Sheffield, and Dr Miguel De Bono, Consultant Endocrinologist at Sheffield Teaching Hospitals, have been awarded £205,000 from the National Institute for Health Research’s prestigious Research for Patient Benefit programme to develop the test with a view to it being available on the NHS within the next three years.
The test offers a simpler and less invasive way to detect adrenal insufficiency – caused by a decrease in cortisol production – by measuring levels of cortisol in saliva instead of in the blood.
The research could lead to the development of an everyday test that can be performed at home by patients and used by all doctors when they suspect adrenal insufficiency. This has the potential to save lives through earlier diagnosis, as well as providing a more cost effective test for the NHS.
Adrenal insufficiency occurs when the body is no longer able to make cortisol – a major hormone that helps the body overcome stress, infections and regulates body sugars, proteins and fats.
At the moment, adrenal insufficiency is diagnosed through a complex blood test which has to be undertaken in a hospital setting.
During the study the researchers will look to establish what levels of cortisol insufficiency need to be present in saliva to give a definitive diagnosis of the condition.
They will do this by comparing the saliva test with the blood tests, with patients having their salivary cortisol tested at home as soon as they wake up and then travelling to hospital immediately afterwards to get the blood tests.
The researchers estimate that the test could dramatically reduce the number of complex investigations for adrenal insufficiency in England by 75 per cent – from approximately 92,000 per year to just 23,000 per year.
Professor Richard Ross, Head of the Academic Unit of Diabetes, Endocrinology and Metabolism and Academic Lead for Innovation at the University of Sheffield, said: “We have worked with Professor Rob Harrison from the University of Sheffield’s Faculty of Engineering to develop the mathematical model showing what levels of cortisol in saliva we should expect.
“We hope this important work will translate our research to date into an everyday test that can be performed at home by patients and used by all doctors when they suspect adrenal insufficiency.
“This has the potential to save lives from early diagnosis as well as providing a more cost effective test for the NHS.”
Dr Miguel De Bono, Consultant Endocrinologist at Sheffield Teaching Hospitals NHS Foundation Trust, said: “Through this research we hope to provide a patient-friendly and more convenient salivary test to reduce and replace the use of the complex tests for the majority of patients.
“Adrenal insufficiency may be difficult to diagnose, particularly as symptoms are non-specific, so as well as providing a more patient-friendly testing option, patients living with this potentially devastating condition will receive quicker diagnosis while also helping the NHS to save money because the new test is less costly.”
The National Institute for Health Research’s (NIHR) Research for Patient Benefit programme aims to fund research projects in health and social care to improve, expand and strengthen the way healthcare is delivered for patients, the public and the NHS.
The research team includes experts from the School of Health and Related Research (ScHARR) as well as a patient co-applicant whose role is to advise on study design and facilitate dissemination and implementation of the study findings.
The study will open for recruitment in October 2019, and will involve 200 patients who are referred for an assessment for adrenal insufficiency at Sheffield’s Royal Hallamshire Hospital.
Laura Duffield, 27, of Kiveton Park, Sheffield, suffers with adrenal insufficiency secondary to pituitary disease and is no longer able to make cortisol naturally after having had her pituitary gland removed following a brain tumour at the age of three.
Ever since, she’s had to take steroids three times a day to help her body do the job that her pituitary gland would have done. But the lack of cortisol in her body makes her more vulnerable to illness.
Laura explained: “I go downhill really, really fast and if I’m unable to take my steroids the consequences can be scary. One time I was rushed into hospital straight away, I was put on an intravenous drip and needed to stay in hospital for four or five days.
“I have to have a blood test every now and again to check my cortisol levels. It’s quite an invasive test and I can’t drive because the pituitary gland caused me to be blind in my left eye.
“The new at-home saliva test is a really good idea as it would be much more convenient for patients like me as I always have to rely on other people to get me to hospital and the blood tests are a time consuming way to test for cortisol insufficiency.”