An observational study in Hyperandrogenism, Metabolic Disease and Sex Hormones Adverse Reaction, sponsored by Royal College of Surgeons, Ireland. Recruiting at 1 site in Ireland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Royal College of Surgeons, Ireland · Observational
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.
Clinical questionnaire and baseline anthropometry:
Study investigators will complete a standardised case record form, with information obtained on relevant medical history, medications and anthropometric assessment (height, weight, body mass index, blood pressure, weight circumference). Body composition will be assessed using a portable bioimpedance machine (Tanita MC-780MA-S Portable). We will also obtain information on education level and household income. Participants will complete a standardised QOL questionnaire.
Serum, urine and saliva sampling:
Fasting bloods will be drawn for assessment of metabolic phenotype including glucose, insulin, lipid profile, full blood count, renal and liver biochemistry and HbA1C. Serum samples will also be obtained for measured of the steroid and non-targeted metabolome. Urine and saliva samples will be obtained for assessment of steroid metabolomics.
Targeted steroid metabolome profiling:
Serum, urinary and salivary multi-steroid profiling including classic and 11-oxygenated androgens will be performed using highly sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS). Furthermore, we will analyse the 24-h urine steroid metabolome, allowing for determination of 24-h net androgen output from classic and 11-oxygenated pathways (26). Analysis will be carried out by LC-MS/MS multi-steroid profiling. Multi-steroid profiling approaches have been developed and optimised at the University of Birmingham Steroid Metabolome Analysis Core (SMAC), where samples will be measured under the supervision of Professor Wiebke Arlt.
Non-targeted serum metabolomics:
The global non-targeted serum metabolome will be profiled at the Phenome Centre Birmingham under the supervision of Professor Warwick Dunn (co-applicant). Samples will be analysed applying Ultra Performance Liquid Chromatography (Ultimate3000RS; Thermo Scientific, Hemel Hempstead, UK) interfaced to an electrospray mass spectrometry (Q Exactive, Thermo Scientific, Hemel Hempstead, UK).
Muscle biopsy:
Under local anaesthetic and without using scalpel incision, muscle biopsies will be obtained from the vastus lateralis muscle of the leg in each participant. These will be performed using a Bard biopsy needle gun, with suction applied to increase tissue yield.
Recruitment:
Patients will be recruited via local advertising in Beaumont Hospital and RCSI Medical School.
81 studies on the registry are indexed under Hyperandrogenism; 22 are open to participants now.
This study's planned enrollment of 500 is above the median of 135 across 26 observational studies indexed under Hyperandrogenism.
Browse Hyperandrogenism studies →Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women meeting the above inclusion criteria without exclusion criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* baseline anthropometry * bloods for metabolic phenotype; targeted and nontargeted Metabolomics * saliva and urine for steroid Metabolomics * bioimpedance * muscle biopsy for transcriptomics
Other: Longitudinal follow up
Repeat follow up at 3,5 and 10 years
Correlation of sex hormone profiles and the metabolome of women across the lifespan with risk of metabolic dysfunction, cardiovascular disease and quality of life.
Time frame: 3 years
Development of risk prediction models for development of diabetes in women
Time frame: 5 years
Establishment of the longitudinal FEMAIL study database
Time frame: 5 years
Plan to share: Undecided — Anonymised data may be made available after consideration of individual access requests, in line with data protection laws and participant consent
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Sep 2025, 53 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Royal College of Surgeons, Ireland