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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Polycystic Ovary Syndrome (PCOS) affects 10% of all women, and it usually co-exists with high levels of male pattern hormones (also termed androgens). Women with PCOS are at increased risk of metabolic complications such as diabetes, non-alcoholic fatty liver disease, high blood pressure and heart disease. However, very little is understood about how androgen excess results in increased metabolic complications observed in women with PCOS. The main aims of the REFUEL PCOS study are to compare markers of energy metabolism in women with PCOS to those without PCOS. This will allow the investigators to better understand metabolic risk by examining the relationship between androgen excess and energy metabolism. Skeletal muscle is an important site of energy metabolism, and emerging theories are that androgen excess impairs skeletal muscle energy balance and increases the risk of complications. Based on these emerging theories, the investigators want to investigate the effects of androgens on muscle energy metabolism. The investigators will also examine whether certain blood and urine result patterns can help identify differences in muscles energy metabolism and which women are at the highest risk of metabolic complications. This research will give insight into the metabolic risk associated with PCOS and treat and, where possible, prevent the development of metabolic disease in affected women.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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⁃ 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)

Locations
Other Locations
Ireland
Royal Collage Of Surgeons
RECRUITING
Dublin
Contact Information
Primary
Michael W O'Reilly, FRCPI PhD
michaelworeilly@rcsi.ie
018093894
Backup
Leanne Cussen, mb bch bao
leannecussen@rcsi.ie
0871344858
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 40
Treatments
Women with PCOS
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
Women without PCOS (controls)
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 20-40kg/m2~* Age range 18-50 years~* Ability to provide informed consent
Sponsors
Leads: Royal College of Surgeons, Ireland
Collaborators: University of Liverpool, University of Birmingham

This content was sourced from clinicaltrials.gov