Hyper-Aid Plus
Research type
Research Study
Full title
Hydrocortisone versus Prednisolone for Treatment of Adrenal Insufficiency Disease: Respiratory and Thrombotic considerations (HYPER-AID plus study)
IRAS ID
281745
Contact name
Robert Murray
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The HYPER-AID study, currently on-going, aims to compare well-being, body composition, lipids, and carbohydrate handling in a cross-over study of standard hydrocortisone regimens and low-dose prednisolone. The Hyper-AID Plus study aims to undertake additional measures to assess how clots are formed and broken down, as well as sleep patterns whilst patients receive hydrocortisone and prednisolone. We will answer the question as to whether these steroids have differential effects on sleep and clot formation, and which would support preferential use of one or other of these steroids for replacement therapy in patients who require long-term steroid replacement due to inability of the body to make the natural steroid, cortisol (adrenal insufficiency).
The aim of this study is to provide further information to determine if there are clinical differences in these regimens (Hydrocortisone or Prenisolone) or if they show equivalence. Additional to end-points documented in HYPER-AID, the HYPER-AID PLUS study proposes assessing some additional outcomes. We are aware that glucocorticoids can lead to sleep disturbance and alter how the body forms clots. The latter, if abnormal may provide a mechanism through which steroids (glucocorticoids) lead to an increase in blood velles related (vascular) morbidity and mortality.
REC name
London - Stanmore Research Ethics Committee
REC reference
21/PR/0140
Date of REC Opinion
29 Mar 2021
REC opinion
Further Information Favourable Opinion