Objective Markers and New Indicators in AI Disease (OMNI-AID Study)
Research type
Research Study
Full title
Objective Markers and New Indicators in Adrenal Insufficiency Disease (OMNI-AID Study)
IRAS ID
216757
Contact name
Karim Meeran
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Adrenal Insufficiency (AI) is a condition in which the body is unable to produce natural steroid hormones which are important at times of stress. Key amongst these hormone is cortisol. This can be because of diseases that affect the adrenal glands (which produce the hormones) or the diseases that affect the pituitary gland in the brain (which controls the adrenal gland).
Patients with AI need to take steroid replacement tablets. Most commonly, they are given hydrocortisone tablets which are taken three times a day. Alternatively, some patients use prednisolone, a tablet taken once a day.
If patients are given too little steroid replacement, they can feel unwell. Symptoms include nausea, vomiting, low blood pressure, low blood sugar and potentially death. If given too much, patients are at risk of heart disease, diabetes, and osteoporosis (weak bones). It is a significant challenge to ensure that patients are receiving the correct dose of steroid replacement, despite our ability to measure steroid levels in the blood.
This study will investigate whether there are any blood tests, urine tests, or other measurements that we can use to ensure that patients are receiving the correct dose of steroid replacement tablets. It will involve healthy volunteers, patients with AI, and patients on steroids for other conditions attending for two visits to complete questionnaires, have measurements recorded (such as weight, blood pressure etc), provide blood samples, and provide urine samples. We will look at a variety of potential objective markers of steroid replacement which are of interest in the current research literature.REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/0607
Date of REC Opinion
27 Apr 2018
REC opinion
Further Information Favourable Opinion