Understanding Androgen Excess and Metabolic Issues in Women with PCOS
Official title: Dissecting Androgen Excess and Metabolic Dysfunction for an Integrated Systems Approach to Polycystic Ovary Syndrome Through the Assessment of Detailed Phenome and Metabolome Data
Run by Imperial College London · NCT03911297 · Data updated 2026-11-12
This study is trying to find out how to predict metabolic problems in women with PCOS by looking at their health data and grouping them based on similar traits.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (Birmingham, West Midlands) |
| Status | Recruiting |
| Started | August 14, 2019 |
| Main results expected | December 31, 2026 |
| Study ends | December 1, 2027 |
| Registry record updated | December 5, 2024 |
| Trial ID | NCT03911297 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18-70 with a suspected diagnosis of polycystic ovary syndrome.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have significant renal or hepatic impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on women diagnosed with polycystic ovary syndrome (PCOS), a condition that affects 10% of women and is associated with metabolic disorders. The researchers aim to identify measurable parameters that can predict the risk of future metabolic diseases in these women by collecting and analyzing phenome and metabolome data. Using machine learning techniques, the study will categorize PCOS patients into distinct subsets based on shared characteristics, which may help in understanding their metabolic risks. The findings could lead to better risk assessment and management strategies for women with PCOS.
Why it matters
Potential benefit: If successful, this study could provide a way to identify women with PCOS who are at higher risk for metabolic diseases, allowing for earlier intervention and personalized treatment.
How similar studies have gone: Previous studies have successfully used similar approaches to identify distinct metabolic markers in other conditions, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with a suspected diagnosis of polycystic ovary syndrome * Age range 18-70 years * 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) * 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 it's running
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Wellcome Trust Clinical Research Facility
Birmingham, West Midlands, United Kingdom Recruiting
Study contacts
- Principal investigator: Wiebke Arlt — University of Birmingham
- Study coordinator: Eka Melson
- Email: e.melson@bham.ac.uk
- Phone: +447852146611
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Precision acupuncture and lifestyle for PCOS
This trial tests whether a precision acupuncture approach combined with a personalized lifestyle plan helps improve insulin resistance in people with PCOS compared with conventional acupuncture and standard lifestyle changes.
-
Orlistat for metabolic and hormonal features in women with PCOS
This trial tests whether adding orlistat to lifestyle advice helps improve metabolic and hormonal aspects in women with PCOS compared to lifestyle advice alone.
-
Physical activity program for women with PCOS and fatty pancreas plus subclinical hypothyroidism
A program of exercise is being tested to see if it helps women with PCOS who also have fatty pancreas and subclinical hypothyroidism, compared to usual care.
-
Glucose monitoring in women with polycystic ovary syndrome
This project will use continuous glucose monitors to see if daily glucose patterns differ among adult women with different PCOS phenotypes.
-
Adding regular exercise to a low‑calorie diet and metformin for women with PCOS and asthma
This study will test whether adding regular treadmill walking to a low‑calorie diet and daily metformin helps women who have both PCOS and asthma.
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Identifying insulin-resistant PCOS with LMNA-related lipodystrophy in young women
We’re testing whether women with a genetic insulin resistance and lipodystrophy differ from women with PCOS by age and BMI matching.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.