CLINICAL TRIAL FOR SALIVA CORTISOL TEST FOR EARLY DETECTION OF ADRENAL INSUFFICIENCY at University of Sheffield Teaching Hospitals

[Pascha1]

I have just been accepted for this trial if you have borderline low serum cortisol You could get your GP to write ask the Drs to let you join the trials :)University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust.

sheffield.ac.uk/news/nr/new...

Just in case link doesn't work I copied and pasted it for you.

New simple test could lead to early detection of cortisol deficiency

New test could dramatically reduce the number of complex investigations for adrenal insufficiency in England by 75 per cent a year - from approximately 92,000 per year to just 23,000

Adrenal insufficiency occurs when the body is no longer able to make cortisol – a major hormone that helps the body overcome stress and infections, and regulates body sugars, proteins and fats

The test will save NHS money and could be available within the next three years

Adrenal insufficiency is currently diagnosed through a complex blood test which has to be done in a hospital

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.

Research Team

Professor Richard Ross and Dr Miguel De Bono and the research team

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 a 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 Department of Automatic Control and Systems Engineering (ACSE) 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, the 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.

Fast facts

There are three types of adrenal insufficiency: primary (Addison’s; adrenal-related), secondary (pituitary-related) and tertiary (patients on long-term steroids). Addison’s is a rare disease, affecting around 100 to 150 people in every million whereas secondary is more common – affecting around 150 to 300 people in every million.

Three per cent of the population is on any type of steroids at any one time, and up to 30 per cent of these suffer with adrenal insufficiency depending on the dose of steroids they have been taking.

The test might need to be repeated for those with secondary and tertiary adrenal insufficiency to test for recovery and by measuring salivary cortisol levels specialists can make a speedier diagnosis reducing the need for prolonged unnecessary steroid treatment.

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.

Laura Duffield

Laura Duffield

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.”

Additional

[nightingale-56]

Thank you for posting this very useful information Pascha1 . My son would also be a good subject for this with his condition of Panhypopituitarism with Septo-Optic Dysplasia, and my Brother, who is suffering after treatment with Steroids for COPD. Good to see they are looking into saliva testing at last.

[SlowDragon Administrator]

Private testing has been using saliva tests for at least 20 years......

[Wired123 in reply to SlowDragon]

Yet every private Endo I have discussed it with (on the supposedly cutting edge Harley Street) has dismissed it as unreliable or claimed to have never heard of such a test! They insist the urinary 24/48 hour is the only one worth doing or the synacthan test

[Pascha1 in reply to Wired123]

What is the range for urine as they only gave me it was ok under 165 no bottom of range told only good for Cushings as not good picking up low quantities ?

[Pascha1 in reply to Wired123]

its a cortisone saliva test not a cortisol saliva test so maybe something they have never heard of, I was to do test last week but cant as lock down grrr

[Pascha1 in reply to SlowDragon]

I know SlowDragon, This is a trial if you read the article is so that the NHS in the future can use Salava Cortisone tests for Adrenal insufficiency which Private tests mean nothing to NHS Dr Endos as they at the moment are only used for Cushings, I posted this so people can go on trials and get this test vallidated for the NHS to use, it will also cost less for the NHS as will also get rid of that awful Snatchen test people have to do and many Drs can not understand the results.. so not the same as the private tests at all as if these trials are good we can all if works out get tested fromat the GPs and will also save NHS loads of money, they probably need more people to trial it.....

[SlowDragon Administrator in reply to Pascha1]

Yes, what I meant was it isn’t cutting edge, the test has been available for at least two decades, but conventionally trained NHS medics not recognising it

Hopefully, moving forward, it will be recognised as relevant

[Pascha1 in reply to SlowDragon]

Is Cortisone saliva test the same as a cortisol one ? well what ever at least they are trying to get on NHS if all works out

[Wired123 in reply to Pascha1]

Thanks for sharing. I think you are referring to the synacthan test? Even private Endos only use that instead of salivary cortisol. So hopefully everyone will start to use the salivary one.

My problem with synacthan is that it only diagnoses people who have completely ineffective adrenals. Those with malfunctioning adrenals are not picked up by synacthan as long as they respond to the extreme stimuli of the test. They do not recreate day to day chronic dysfunction.

I’m going to try and get onto the trial as well.

[Pascha1 in reply to Wired123]

Good luck, Yes I was told about the Synacthen test it only really picks up at levels where like if you had major surgery its only really good when you are just about dead in most people they are more ignorant on the Adrenals than they are the Thyroid I didnt think that was possible but it is , and really what is needed is a 24 hr cortisol Profile but Adult Endos dont like doing that as it means taking up a bed for the night,, not good is it .

This will be a major brek through if they bring it out on NHS I bet Addisons is not as rare as they think

Rare the Drs seem to think you wont get it but to me I think rare should be they should be aware it can and doeshappen ..

I posted this as know many who have the SST test have low am cortisol but stim ok but many things like medications will make you stim well and you feel quite the opposite also 3 types of Adrenal insufficiency but most Endos dont seem to know that the ignorance on it all is scary

I hope others do try to get on it,

The Dr that called me back was Maltese he is really nice

Good luck getting on the trial please let me know if you get on it

I will find the secretary number for you a little later and message it to you if you would like , I called them was told to email then Dr called me back and then he asked me to get GP to email him

I am just off out with the dogs now

[debsmitch60 in reply to Pascha1]

Pascha1 I have just come across this post and read the comments. Did you get onto the trial and is it still open to people as I would also like to apply if I could. x

[Pascha1 in reply to debsmitch60]

yes but because of lockdown havent been yet, I got sent the saliva sample pot but amn to go to shefield to do a short synacthen test,, But I dont think will go now as my cortisol levels are 75 nmol now so seeing Endo 1st week in April, Its a long way for me and got little energy now,,, but the trials are still going on should you want to do it I am going to cancel my place on Monday as just way to far for me feeling like crap

[debsmitch60 in reply to Pascha1]

Do you think they are still taking people for the trial? And is there a number or email you could tell me please if so. What does 75 nmol mean, is that low? I am always feeling so ill too and I'm sorry you are too x

[Pascha1 in reply to debsmitch60]

I will look the numbup later fo you .. 75 nmol the range was 166-507 so was below range and really should of been sent straight to an Endo as guidelines say anything below 100 put on steroids and send straight to hospital that was 3 weeks ago and my appoint ment isnt til the end of the 1st week in April so they dont seem to think its urgent, I think also because Covid think endocrine seems to not be doing full dervice re COVID, seen a few on Fb with cortisol just a bit higher than mine although getting quicker appointments than me, tbh I have been waiting over a year and half to be retested as was on drugs that artificialy inflated cortisol.. its hard work.... what are your levels then, You will need to get an early 8-9am serum cortisol of your Dr, I think need to fit certain criteria to go on that clinical trial so that will need to be done bbefore you apply I will try find number for you but you could just ring sheffield hospital and ask for Dr De Bonos secretary she has all the details

[debsmitch60 in reply to Pascha1]

Thank-you and omg that's so bad that they are making you wait. Can I ask what drugs artificially inflate cortisol please? My blood test was in the lower third before SST which said I was fine. I have had 2 different saliva tests including dhea Dec 2019 and May 2020 that shows I'm low in both. I don't know why my blood is showing its okish but saliva is not.

Another Endo wants me to go in for the day for different tests but I don't know what. He also said long term use of opiates messes with your adrenal system and makes cortisol lower.

Thank-you for replying and hope they sort you out soon x

[Pascha1 in reply to Wired123]

My predict is on one today yes I meant Synacthen test

[Wired123 in reply to Pascha1]

It’s more about money, if there was money to be made from treating adrenal dysfunction with a drug then pharma companies would be lining up trials to come up with undiagnosed candidates for their new drug.

I’ve worked in pharma so sadly am very cynical.

There’s plenty of people with messed up adrenals thanks to modern lifestyles and can be offered very simple treatment which does not always require drugs.

I am reading a lot about how adrenal dysfunction goes hand in hand with thyroid problems. I can certainly relate to that and it’s very plausible.

I’ve just started reading Paul Robinson’s book on thyroid disease and he talks a lot about low cortisol and how to treat it.

[Pascha1 in reply to Wired123]

I take my T3 in the way Paul Robinson says in his book, it has raised cortisol a bit but not enough My GP thinks my adrenals are caused by me badly treated thyroid , I had graves years ago one auto immune many others follow I didnt know that till a year ago I had thryoidectomy done in 1983 some one could of old me , I have pernicious anemia as well

[humanbean]

NASA has been investigating and using saliva samples from their astronauts for many years to determine levels of cortisol and other hormones e.g. melatonin.

I found this reference on Google Scholar, for example, and it was published in 1992 :

ntrs.nasa.gov/citations/199...

To find the above I just searched Google Scholar for "saliva cortisol nasa" i.e. :

scholar.google.co.uk/schola...

If you go to the NASA website and do a search for "cortisol" and "saliva" or "salivary" you'll find many more recent references (mostly from 2017, but some others too).

[Pascha1 in reply to humanbean]

I will look at links a bit later thank you

Problem is would they be sending anyone up to space with Adrenal insufficiency ? maybe this is why they do not have enough evidence ofr AI and lower cortisol levels

[humanbean in reply to Pascha1]

Doctors in the UK often pour scorn on saliva testing for testing adrenal health. I was just mentioning that NASA has been monitoring their astronauts using saliva testing for many years, not just for cortisol but for other hormones too. The technique has a good pedigree.

I wasn't suggesting that NASA sends astronauts into space with adrenal insufficiency.

[Pascha1 in reply to humanbean]

The NHS are not cutting edge they are way behind times probably because NICE guidelines which seem to not let Drs think outside the box and is all about cost.

Or as Anthony Toff says the patients are way ahead of the game in thyroid so appears we are on Adtrenals also..

Would be better to have saliva testing for Thyroid testing esp T3 probably be cheaper for nhs saliva testing than the blood samples which I have been told by many Drs that Thyroid bloods are flawed as are Diabetes and B12 testing

it makes sense to test free cortisol as so many meds can affect Cortisol Binding and ACTH meds such such as Citralapam, oral Oestregen HRT, the pill they say the HRT patch doesnt affect cortisol but on EMC says it raises serum cortisol I asked a bio chemist whos just retired and she said it does by 8-12% why Endos do not know any of this is beyond me and I think where they have employed cheap labour all this goes un noticed also many CNS stimulants raises serum Cortisol and ACTH quite significantly , it wouldnt suprise me if nicotine and caffiene also affect serum cortisol and many more meds that affect the HPA system so that Synacthen test is flawed in many ways Im trying to work out how CNS drugs actually raise cortisol but cant quite understand it all yet.

This trial is testing Saliva cortisone is that the same as cortisol ?

[humanbean in reply to Pascha1]

I never use the word cortisone, I only ever use the word cortisol. I have no idea whether I'm using the word correctly or not.

differencebetween.com/diffe...

[Pascha1 in reply to humanbean]

Ive never called it that either I wonder if this saliva cortisone test is different to the saliva cortisol test ? so myabe a completely new test that private companies use ?

[Pascha1 in reply to humanbean]

Just found this sheffield.ac.uk/polopoly_fs...

[Pascha1 in reply to humanbean]

My GP when I showed him my saliva cortisol said we do ot normally take notice of saliva testing but said he would do a 8am cortisol test so went in next day mine came back at 140 he called later shocked it was so low, my saliva cortisol I think was about 3 under range so really they both showed I was low I am on a med that raises CBG but even with evidence from the drug company I was ignored by NHS Endos I cant afford private but even seeing Private I see people saying they are being ignored on Adrenals so no hope here why are endos not taught these drugs affect cortisol levels its quite negligent as I dont think CBG can save your life if you have a crisis as what I have researched is CBG when you are unwell will not last very long so therefor could danger your life.

[endomad]

This is the first time I have heard of someone else losing their sight after cortisol/stim test, it was scary and lasted 5 days virtual blindness and 2 more days for it to clear, no one knows why.

My cortisol was tested twice 2016 107(150-550) 2018 95(150-550) mine is secondary as when stimmed it shot up to 650. I havev yet to find any Dr who knows what to do about it.

[Pascha1 in reply to endomad]

My GP didnt think I had secondary AI as people with pituitary problem lose eye sight in one side of eye, so you Endo should be doing other tests for pituitary did they not do ACTH test at same time as they should of if you had such low cortisol on stim test,, , take a look at this wesite it may have some answers and tells you what other tests you should have for testing pituitary, . My Endo never tested my ACTH with synacthen test either

pituitary.org.uk/news/2017/...

They have a a help line most who answer phone line have pituitary problems and will help you if you have any questions and they also have a very good nurse in somedays of the week, both the help line and the nurse have a list of Endos who understand pituitary problems I would suggest you give them a call they are very knowkledgable and helpful.. the Synatchen test is really only good for testing Addisons when 90 % daamge is caused and you will need other testing for secondary AI ,

good luck but the website is worth looking at if you havent see it all ready after you talk to them let me know how you got on please just leave comment on here or private message me so can see it, you will need other hormones testing if they havent done already,

[endomad in reply to Pascha1]

My Endo is good re thyroid but he doesn't know about cortisol unless addison's or cushing's, anything in-between not his specialty, he tried to find a specialist for me but no luck. I will check out the link, thanks