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FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study

Recruitingn/aAges 18 Years - anyFemaleRoyal College of Surgeons, Ireland
NCT04912648 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Androgen excess is the cardinal biochemical feature of polycystic ovary syndrome (PCOS), a lifelong metabolic disorder affecting 10% of women. Serum testosterone correlates with insulin resistance in women, however, there is an urgent need to improve our understanding of the association between androgens and the risk of type 2 diabetes. Recently, a new subclass of androgenic steroids known as 11-oxygenated androgens has been identified. Utilising highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) techniques, our group has recently demonstrated that 11-oxygenated steroids are the predominant androgens in both health controls and women with PCOS, and that these correlate closely with markers of insulin resistance. The bioactive 11-oxygenated androgen 11-ketotestosterone (11KT) binds and activates the androgen receptor with equal affinity to testosterone, yet nothing

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or above * Ability to provide informed consent Exclusion Criteria: * Pregnancy or breastfeeding at the time of planned recruitment * History of significant renal (eGFR\<30) or hepatic impairment (AST or ALT \>two-fold above ULN; pre-existing bilirubinaemia \>1.2 ULN) * The investigators will retain the right not to recruit potential participants with severe health disorders which may impact on their ability to participate in the study; these may include, but are not limited to, metastatic cancer, severe cardio-respiratory disease or other life-limiting health disorders * Participants who have participated in another research study involving an investigational medicinal product in the 12 weeks preceding the planned recruitment * Glucocorticoid use via any route within the last six months * Current intake of drugs known to impact upon steroid or metabolic function or intake of such drugs during the six months preceding the planned recruitment * Use of combined oral hormonal contraception in the three months preceding the planned recruitment
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What it tests

  • Longitudinal follow up
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Where

1 site
Royal College of Surgeons in Ireland
Dublin, Ireland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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