Actively Recruiting
Dissecting Androgen Excess and Metabolic Dysfunction for an Integrated Systems Approach to Polycystic Ovary Syndrome Through the Assessment of Detailed Phenome and Metabolome Data
Led by Imperial College London · Updated on 2024-12-05
1000
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
U
University Hospital Birmingham NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Polycystic ovary syndrome (PCOS) affects about 10% of women and is characterized by irregular periods and fertility challenges. It is also a lifelong metabolic disorder linked to higher risks of type 2 diabetes, high blood pressure, and heart disease. This study aims to identify subsets of women with PCOS who are at the highest risk of developing metabolic diseases by assessing their clinical signs, androgen levels, and metabolic function using detailed phenome and metabolome data.
CONDITIONS
Brief Title
DAISy-PCOS Phenome Study - Dissecting Androgen Excess and Metabolic Dysfunction in Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a suspected diagnosis of polycystic ovary syndrome
- Age between 18 and 70 years
- Ability to provide informed consent
You will not qualify if you...
- Pregnancy or breastfeeding at the time of planned recruitment
- History of significant kidney impairment (eGFR <30) or liver impairment (AST or ALT more than twice upper limit of normal; bilirubinaemia >1.2 times upper limit)
- Any other significant disease or disorder that may pose risk or affect ability to participate or study results
- Participation in another investigational medicinal product study within 12 weeks before recruitment
- Use of glucocorticoids in any form within the last six months
- Current or recent (within six months) use of drugs affecting steroid or metabolic function
- Use of oral or transdermal hormonal contraception within three months before recruitment
- Use of contraceptive implants within twelve months before recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over time to collect detailed phenome and metabolome data to assess metabolic risk related to polycystic ovary syndrome.
Periodic assessments during the study period
Trial Site Locations
Total: 1 location
1
Wellcome Trust Clinical Research Facility
Birmingham, West Midlands, United Kingdom, B15 2TT
Actively Recruiting
Research Team
E
Eka Melson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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