Urine free cortisol method and reference range determination study
Research type
Research Study
Full title
Development of a liquid chromatography – tandem mass spectrometry method for the measurement of urine free cortisol and determination of a reference range in an obese and non-obese adult population
IRAS ID
199473
Contact name
Ellen Rumsby
Contact email
Sponsor organisation
University Hospital Southampton
Duration of Study in the UK
0 years, 11 months, 2 days
Research summary
Cortisol is a steroid hormone produced by the adrenal glands in response to adrenocorticotropic hormone secreted by the pituitary which in turn is regulated by corticotropin releasing hormone from the hypothalamus. The major roles of cortisol are in mediating the response of the body to stress. Cushing's syndrome is characterised by excess cortisol production and its associated clinical features are due to the glucocorticoid effects of excess cortisol. Clinical features of Cushing's syndrome are broad and non-specific including abdominal obesity, striae and glucose intolerance. Diagnosis of Cushing's syndrome can be challenging especially in mild cases due to the range of symptoms and their overlap with other clinical conditions.
Obesity and the metabolic syndrome are considered a global health problem associated with an increase in co-morbidities such as diabetes and cardiovascular disease and characterised by the metabolic syndrome. There is a significant overlap between the clinical presentation of Cushing’s syndrome and the metabolic syndrome and a causal relationship between cortisol and obesity/ the metabolic syndrome has been suggested.
Measurement of urine free cortisol (UFC) is used to assess whether excess cortisol is being produced. UFC is currently measured in the laboratory by immunoassay however due to cross-reacting compounds within urine these types of assay overestimate the result. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is more frequently being used in diagnostic laboratories as it overcomes some of the interference affects. Measurements of UFC by LC-MS/MS produces significantly lower results than immunoassay.
There is currently no published data on UFC concentrations measured by LC-MS/MS in obese patients who do not have Cushing’s syndrome. The aim of this study is to develop and validate a LC-MS/MS assay for the measurement of UFC and determine a reference range for UFC in both obese and non-obese populations.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
16/SC/0305
Date of REC Opinion
26 May 2016
REC opinion
Favourable Opinion