The Pulses Study
Research type
Research Study
Full title
Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia
IRAS ID
98045
Contact name
Stafford Lightman
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Eudract number
2012-001104-37
Research summary
Cortisol (also called hydrocortisone) is a hormone produced by the adrenal glands that is essential for life. It is produced in a daily (circadian) rhythm with high levels first thing in the morning, falling to very low levels at night time. There are many medical conditions such as Addison's disease, congenital adrenal hyperplasia and pituitary disease where patients cannot produce enough of this hormone and therefore require replacement therapy. At present we give patients standard replacement therapy with tablets in an attempt to mimic a normal hormonal profile. However despite this their death rates remain twice that of the background population (similar to the increased risk from smoking) and patients often feel generally unwell with severe fatigue. It is now known cortisol is released into the blood stream in pulses, and that this pattern is vital for the body's normal responses. Unfortunately this pulsatile pattern is not the pattern of replacement that we currently give and this could contribute to the excess death rate and poor quality of life of these patients. We propose to deliver pulses of hydrocortisone under the skin in a way that closely mimics natural hormone release. We intend to trial this in patients with Addison's and congenital adrenal hyperplasia. We shall assess the effectiveness of the treatment by measuring their hormone levels, metabolic profiles, quality of life and cognitive and emotional processing using psychological tests and MRI scanning that are specifically tailored to the symptoms of our patients.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1050
Date of REC Opinion
6 Oct 2014
REC opinion
Further Information Favourable Opinion