Actively Recruiting
FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study
Led by Royal College of Surgeons, Ireland · Updated on 2024-05-02
500
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on understanding the role of androgen hormones in women's metabolic health, especially related to polycystic ovary syndrome (PCOS) and type 2 diabetes risk. It highlights a new class of androgens called 11-oxygenated androgens, which may influence metabolism and glucose regulation in women across their lifespan. The study aims to explore how these androgens correlate with insulin resistance and metabolic disease in women, including those without a confirmed PCOS diagnosis. Participants will undergo detailed assessments including a clinical questionnaire, physical measurements like height, weight, and body composition using a portable device, and blood pressure readings. Blood, urine, and saliva samples will be collected to analyze steroid hormones and metabolites using advanced laboratory techniques. Muscle biopsies will be taken to study gene activity related to metabolism. The study includes follow-up visits at 3, 5, and 10 years to monitor changes over time. Women in the study will complete quality of life questionnaires and provide samples for extensive metabolic and steroid hormone profiling. Researchers will assess blood sugar, insulin, lipids, kidney and liver function, and hormone levels. Muscle tissue samples will help understand metabolic processes at a cellular level. The main goal is to correlate hormone profiles with metabolic health and cardiovascular risk over three years, with longer-term aims to develop diabetes risk prediction models and build a comprehensive study database.
CONDITIONS
Brief Title
FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above
- Ability to provide informed consent
You will not qualify if you...
- Pregnancy or breastfeeding at the time of planned recruitment
- History of significant kidney impairment (eGFR less than 30)
- History of significant liver impairment (AST or ALT more than twice the upper limit of normal; bilirubin greater than 1.2 times normal)
- Severe health disorders that may affect participation, such as metastatic cancer or severe heart or lung disease
- Participation in another investigational drug study within 12 weeks before recruitment
- Use of glucocorticoids by any route within the last six months
- Current or recent (within six months) use of drugs affecting steroid or metabolic function
- Use of combined oral hormonal contraception within three months before recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants complete questionnaires and undergo physical measurements including height, weight, body mass index, blood pressure, waist circumference, and body composition using a portable bioimpedance machine. Blood, urine, and saliva samples are collected for metabolic and steroid profiling. A muscle biopsy is performed under local anaesthetic.
1 visit (in-person)
Duration - Up to 10 years
Participants are followed up with repeat assessments at 3, 5, and 10 years to monitor metabolic risk and hormone profiles over time.
3 visits over 10 years
Trial Site Locations
Total: 1 location
1
Royal College of Surgeons in Ireland
Dublin, Ireland, D9
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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