Actively Recruiting

Age: 18Years - 70Years
FEMALE
NCT03911297

DAISy-PCOS Phenome Study - Dissecting Androgen Excess and Metabolic Dysfunction in Polycystic Ovary Syndrome

Led by Imperial College London · Updated on 2024-12-05

1000

Participants Needed

1

Research Sites

433 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 10% of all women and usually presents with irregular menstrual periods and difficulties conceiving. However, PCOS is also a lifelong metabolic disorder and affected women have an increased risk of type 2 diabetes, high blood pressure, and heart disease. Increased blood levels of male hormones, also termed androgens, are found in most PCOS patients. Androgen excess appears to impair the ability of the body to respond to the sugar-regulating hormone insulin (=insulin resistance). The investigator has found that fat tissue of PCOS patients overproduces androgens and that this can result in a build-up of toxic fat, which increases insulin resistance and could cause liver damage. In a large cohort of women registered in a GP database, the study team have found that androgen excess increases the risk of fatty liver disease. The aim is to identify those women with PCOS who are at the highest risk of developing metabolic disease, which would allow for early detection and potentially prevention of type 2 diabetes, high blood pressure, fatty liver and cardiovascular disease. The investigator will assess clinical presentation, androgen production and metabolic function in women with PCOS to use similarities and differences in these parameters for the identification of subsets (=clusters) of women who are at the highest risk of metabolic disease. The investigator will do this by using a standardised set of questions to scope PCOS-related signs and symptoms and the patient's medical history and measure body composition and blood pressure. This standardised recording of a patient's clinical presentation (=clinical phenotype) is called Phenome analysis. The investigator will collect blood and urine samples for the systematic measurement of steroid hormones including a very detailed androgen profile (=steroid metabolome analysis) and of thousands of substances produced by human metabolism (=global metabolome analysis). Phenome and metabolome data will then undergo integrated computational analysis for the detection of clusters predictive of metabolic risk.

CONDITIONS

Official Title

DAISy-PCOS Phenome Study - Dissecting Androgen Excess and Metabolic Dysfunction in Polycystic Ovary Syndrome

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with a suspected diagnosis of polycystic ovary syndrome
  • Age range 18-70 years
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding at the time of planned recruitment
  • History of significant renal impairment (eGFR <30)
  • History of significant hepatic impairment (AST or ALT > two-fold above ULN; pre-existing bilirubinaemia >1.2 ULN)
  • Any other significant disease or disorder that may put the participant at risk, influence study results, or affect participation, as judged by the Investigator
  • Participation in another research study involving an investigational medicinal product within 12 weeks before planned recruitment
  • Use of glucocorticoids by any route 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 in the three months before planned recruitment
  • Use of contraceptive implants in the twelve months before planned recruitment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Wellcome Trust Clinical Research Facility

Birmingham, West Midlands, United Kingdom, B15 2TT

Actively Recruiting

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Research Team

E

Eka Melson

CONTACT

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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