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

Recruiting now

Conditions studied: Hyperandrogenism, Metabolic Disease, Sex Hormones Adverse Reaction

In brief

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 is known about its impact on metabolism or glucose homeostasis. Intriguingly, unlike testosterone, 11-oxygenated androgens do not decline with age in women, and, therefore, may mediate an increased risk of T2DM in women across their life course. Therefore, this previously ignored androgen class is likely of major importance in female metabolic health, and may represent a novel metabolic risk factor and biomarker. However, 11-oxygenated androgens are not currently measured in routine clinical practice. To date, no population-based or human in vivo physiology studies have examined the association between 11-oxygenated androgens, glucose metabolism and diabetes risk in women, despite the high prevalence of PCOS in the female population. There is emerging evidence, even in women without a confirmed history of PCOS, that the levels of androgens over time correlate with their likelihood of developing metabolic and cardiovascular disease. This has not been studied to date in a prospective manner in healthy women in the background population using long term follow up data.

Key facts

Study ID: NCT04912648
Run by: Royal College of Surgeons, Ireland
People needed: 500
Starts: 2021-04-01
Expected to finish: 2031-08-31
Last updated by the study team: 2024-05-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Age 18 years or above
Ability to provide informed consent

You may not qualify if…

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

Where it is running

Royal College of Surgeons in Ireland — Dublin, Ireland (enrolling)

Full record on ClinicalTrials.gov

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