Understanding energy metabolism in women with Polycystic Ovary Syndrome

The RolE oF Androgen Excess in MUscle Energy MetaboLism in Women With PolyCystic Ovary Syndrome (The REFUEL PCOS) Study 1

This study looks at how high levels of certain hormones in women with Polycystic Ovary Syndrome (PCOS) affect their energy use and could lead to health issues like diabetes and heart disease.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Royal College of Surgeons, Ireland (Academic / other)
• Locations: 1 site (Dublin)
• Trial ID: NCT05973175 on ClinicalTrials.gov

What this trial studies

The REFUEL PCOS study aims to investigate the relationship between androgen excess and energy metabolism in women diagnosed with Polycystic Ovary Syndrome (PCOS). By comparing metabolic markers in women with PCOS to those without, the study seeks to elucidate how androgen levels may contribute to increased metabolic risks such as diabetes and cardiovascular disease. The research focuses on the role of skeletal muscle as a critical site for energy metabolism, exploring how androgen excess may impair its function. This observational study will provide insights into the metabolic complications associated with PCOS, which is often overlooked in traditional approaches.

Who should consider this trial

Good fit: Ideal candidates include women aged 18-50 with a confirmed diagnosis of PCOS characterized by androgen excess.

Not a fit: Patients without clinical features of PCOS or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of metabolic risks in women with PCOS, potentially guiding future therapeutic strategies.

How similar studies have performed: While studies have explored aspects of PCOS and metabolic health, this specific focus on androgen excess and energy metabolism is relatively novel.

Eligibility criteria

Inclusion Criteria:

-

The following inclusion criteria need to be met for the PCOS Study participants:

* Women with a confirmed diagnosis polycystic ovary syndrome with androgen excess on clinical or biochemical grounds
* BMI 20-40kg/m2
* Age range 18-50 years
* Ability to provide informed consent

The following inclusion criteria need to be met for the control Study participants:

* No clinical features of possible polycystic ovary syndrome (absence of clinical features of androgen excess and ovulatory dysfunction).
* BMI 20.0-40kg/m2
* Age range 18-50 years
* Ability to provide informed consent

For participants with PCOS, a diagnosis of PCOS should be established on the basis of the Androgen Excess and PCOS (AE-PCOS) Society guidelines:

* Androgen excess (clinical and/or biochemical evidence)
* Chronic oligo-/anovulation (clinical and/or biochemical evidence)
* Clinical and/or biochemical exclusion of other conditions that could explain the above manifestation (e.g. congenital adrenal hyperplasia, Cushing's syndrome, Prolactinoma, adrenal and gonadal tumours)

Exclusion Criteria:

* The participant may not enter the study if ANY of the following apply:

  * 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 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 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

Where this trial is running

Dublin

• Royal Collage Of Surgeons — Dublin, Ireland (Recruiting)

Study contacts

• Study coordinator: Michael W O'Reilly, FRCPI PhD

Conditions Polycystic Ovary Syndrome