Plenadren versus Hydrocortisone in Primary Hypoadrenalism - Version 1
Research type
Research Study
Full title
Observational Comparison of Plenadren VS Hydrocortisone in the treatment of Primary Hypoadrenalism (Addison's Disease): Exploration of the effects on body composition, metabolic profiles and adipose tissue functioning.
IRAS ID
189425
Contact name
Daniel K. Border
Contact email
Sponsor organisation
Warwick Medical School, University of Warwick
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Background: Hypoadrenalism is a condition in which the adrenal glands fail to produce sufficient amounts of steroid hormones. Both primary (adrenal glands themselves fail) and secondary hypoadrenalism (hormonal drive to stimulate the adrenal glands is lost) exist. In this study we focus on primary hypoadrenalism, usually treated with the oral medication hydrocortisone (a preparation of steroid replacement). This is administered as three doses throughout the day, usually at 10mg/5mg/5mg, attempting to replicate the physiological profile of adrenal steroids, the levels of which drop from a peak in the morning to a trough at midnight. The half-life of hydrocortisone is very short though, resulting in fluctuations in steroid level, and this does not achieve a particularly physiological profile.
Aim/rationale: Our study aims to explore the effects of a modified-release steroid preparation, plenadren. The aim will be to compare the effects of standard hydrocortisone treatment with plenadren, on metabolism, fat tissue, and body composition.
Methodology: We will recruit 16 adult participants with confirmed hypoadrenalism, already on either Plenadren or standard hydrocortisone therapy. Participants will be recruited from Oxford and Coventry hospitals. The participants will firstly undergo a full metabolic assessment in the Human Metabolism Research Unit (HMRU) in Coventry. The visits will last 24 hours, during which the participants will have energy expenditure measured in the whole body calorimeters; blood, saliva and urine sampling; and a fat tissue biopsy taken from the abdominal area. The participants will also undergo an ‘IDEAL MRI’ scan to assess their brown fat mass - metabolically active fat tissue known to impact on energy expenditure. Following their initial assessment, participants will undergo 6 months continued therapy. At 6 months, a repeat metabolic assessment will take place as above, following which they will continue with a further 6 months therapy. At 12 months, a final metabolic assessment will take place.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0018
Date of REC Opinion
17 Mar 2016
REC opinion
Further Information Favourable Opinion