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

Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Jun 2, 2021

Keywords

ClinConnect Summary

The FEmale Metabolic Risk and Androgens (FEMAIL) Study is researching the relationship between certain hormones called androgens and the risk of developing type 2 diabetes in women, particularly those with polycystic ovary syndrome (PCOS). PCOS is a common condition affecting many women, and understanding how androgens like 11-ketotestosterone impact metabolism and glucose levels could help identify new risk factors for diabetes. This study aims to learn more about these hormones in women over time, especially since they may not decrease with age like other hormones do.

To join the study, participants need to be at least 18 years old and able to give consent. However, women who are pregnant, breastfeeding, or have certain health issues may not be eligible. During the study, participants will undergo assessments to help researchers understand how androgens affect their metabolic health. This is an important step in exploring new ways to identify and manage diabetes risk in women, especially considering the high number of women affected by PCOS.

Gender

FEMALE

Eligibility criteria

• 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