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

Summary

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

• Polycystic Ovary Syndrome

Interventions

OTHER

Women with polycystic ovary syndrome

Prospective cohort study in women with polycystic ovary syndrome to identify the risk of developing metabolic disease

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Birmingham Women's and Children's NHS Foundation Trust

  collaborator OTHER

• University Hospital of Wales

  collaborator OTHER

• University Hospitals Coventry and Warwickshire NHS Trust

  collaborator OTHER

• Royal Infirmary of Edinburgh

  collaborator OTHER

• Royal College of Surgeons, Ireland

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Hull University Teaching Hospitals NHS Trust

  collaborator OTHER_GOV

• King's College Hospital NHS Trust

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Wiebke Arlt · University of Birmingham

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-14

Primary Completion

2026-12-31

Completion

2027-12-01

Countries

• United Kingdom

Study Locations