11-oxygenated androgens and metabolic risk stratification in PCOS.
Research type
Research Study
Full title
The clinical utility of a group of 11-oxygenated androgens as novel biomarkers for diagnosis, sub-categorisation and metabolic risk stratification in polycystic ovary syndrome (PCOS), including the establishment of levels within a reference population.
IRAS ID
333226
Contact name
Katie Allen
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Duration of Study in the UK
7 years, 6 months, 25 days
Research summary
Polycystic ovary syndrome (PCOS) is a condition that can affect the appearance, fertility and long-term health of patients who suffer from it. This project aims to investigate the potential role of a particular group of hormones (referred to as the 11-oxygenated androgens) in the diagnosis of PCOS, and explore the relationship between these hormones and markers of long-term health risks (metabolic profile). If found to be useful, measurement of these hormones may increase the testing available for women with PCOS in order to better understand their condition and the long-term health implications.
The study will involve collecting urine, blood and saliva samples from a group of adult women with PCOS, and a group of adult women who do not have PCOS. This will allow determination of the expected levels of these hormones in a normal population, so that levels in women with PCOS with different metabolic profiles can be compared. The group of women with PCOS will be followed up annually for 5 years to determine how levels of these hormones and metabolic profiles might change over time. All participants will be asked to attend a clinic for a physical examination and fasting sample collection. This means they will be asked to not eat or drink anything except water for 8 hours before their appointment. They will also be asked to complete a series of brief questionnaires about their health and quality of life.
The study results will be written up as part of a Doctoral level qualification with the University of Manchester, therefore it is funded by Health Education England. It will take place at the Academic Diabetes, Endocrinology and Metabolism, Allam Diabetes Centre at Hull Royal Infirmary.
REC name
London - Fulham Research Ethics Committee
REC reference
24/PR/0151
Date of REC Opinion
8 Mar 2024
REC opinion
Further Information Favourable Opinion