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Research type
Research Study
Full title
Predicting the Undesired effects of Steroid Hormones through Urinary steroid Profiles
IRAS ID
238273
Contact name
Jeremy Tomlinson
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Eudract number
2016-003060-40
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Summary of Research
2-3% of the population of the UK are prescribed steroid treatment to treat a wide variety of conditions. Whilst steroid treatment is very effective, it is associated with significant side effects that can include weight gain, the development of diabetes, high blood pressure, fat in the liver and thinning of the muscles. Currently there are no explanations on the reason why the side effects of steroid medication are not the same in all subjects.
In working leading up to this study, we have shown that an enzyme called 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) generates additional steroid to those that are administered and this can further amplify the detrimental actions of steroids (notably in muscle, liver and fat). We have shown that animals that lack 11β-HSD1 are protected from the side effects of administered steroids. We believe that 11β-HSD1 activity is responsible for the differing degrees of side effects experienced by patients arising from prescribed steroids. We will use a steroid medication that is very commonly prescribed in clinical practise, called Prednisolone, in healthy volunteers to see if the different levels of activity of 11β-HSD1 can predict the development of side effects.
Investigations will be performed before and after one week of treatment. The tests that we will perform will aim to show the difference on the undesired effects of prednisolone in those volunteers having high or low activity of 11β-HSD1.Summary of Results
The study has shown that prednisolone is metabolised very differently by healthy individuals and that this may have consequences for how it acts, for the benefits that it conveys as well as the potential to develop undesirable side effects. The information that was generated as part of this study has helped to inform and design future studies that will try to adopt a precision approach to prescribing steroids to patients in an attempt to maximise their benefit and minimise harmful side effects.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0038
Date of REC Opinion
21 Feb 2018
REC opinion
Further Information Favourable Opinion