The RolE oF Androgen Excess in MUscle Energy MetaboLism in Women With PolyCystic Ovary Syndrome (REFUEL PCOS) Study 2

Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Dec 2, 2022

Keywords

ClinConnect Summary

Background:

Polycystic ovary syndrome (PCOS) is a lifelong metabolic disorder affecting 10-13% of all women and is associated with major healthcare and economic burden, estimated at $8 billion annually the US in 2020. Traditionally considered a reproductive disorder only, it is now increasingly clear that PCOS is associated with severe metabolic health consequences across the entire life course of women. There is a two-fold increased risk of type 2 diabetes mellitus (T2DM), nonalcoholic fatty liver disease, and emerging evidence of increased cardiovascular disease (CVD) incidence. There ar...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with a confirmed diagnosis of polycystic ovary syndrome with androgen excess on clinical or biochemical grounds
• • BMI 20-40kg/m2
• • Age range 18-40 years
• • Ability to provide informed consent
• • Negative pregnancy test at screening
• • Effective method of contraception (will sign a pregnancy waiver)
• Exclusion Criteria:
• • A confirmed diagnosis of diabetes
• • Current or recent (\<3 months) use of weight loss medications
• • Current or recent use of oral contraceptive pill or hormone replacement therapy (within last 3-months)
• • Blood haemoglobin \<11.0g/dL
• • History of alcoholism or a greater than recommended alcohol intake (recommendations \> 21 units on average per week for men and \> 14 units on average per week for women)
• • Haemorrhagic disorders
• • Treatment with anticoagulant agents
• • Other co-morbidities that in the view of the investigators may affect data collection
• • Any medical condition in the opinion of the investigator that might impact upon safety or validity of the results
• • Pregnancy or breastfeeding at the time of planned recruitment
• • A diagnosis of PCOS according to Rotterdam criteria where the patient does not have clinical or biochemical evidence of androgen excess
• • History of significant renal (eGFR\<30) or hepatic impairment (AST or ALT \>two-fold above ULN; pre-existing bilirubinaemia \>1.2 ULN)
• • Any other significant disease or disorder that, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• • 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 three 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 oral or transdermal hormonal contraception in the three months preceding the planned recruitment
• • Use of contraceptive implants in the twelve months preceding the planned recruitment