RecruitingOBSERVATIONAL

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

This study aims to understand why some women with Polycystic Ovary Syndrome (PCOS) are at a higher risk of developing health problems like type 2 diabetes, high blood pressure, and heart disease. PCOS can also involve higher levels of male hormones, which might make it harder for the body to use insulin properly. Researchers will collect information about symptoms, medical history, body measurements, and blood/urine samples from women with PCOS. They will then use computers to find patterns, or 'clusters,' among the participants to identify those most at risk. The goal is to find ways to detect and potentially prevent these health issues earlier.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

1,000

Start

14 Aug 2019

Estimated completion

01 Dec 2027

Polycystic Ovary Syndrome

What is this study about?

Polycystic Ovary Syndrome (PCOS) is a common condition affecting many women, often causing irregular periods and making it harder to get pregnant. But it's also a lifelong condition that can increase the risk of other health problems like type 2 diabetes, high blood pressure, and heart disease. Many women with PCOS have higher levels of male hormones, and these hormones might affect how your body uses insulin, which controls blood sugar.

Researchers have noticed that the fat tissue in women with PCOS can produce extra male hormones. This might lead to a build-up of unhealthy fat, making the body less responsive to insulin and potentially causing liver damage. They've also seen that higher levels of male hormones can increase the risk of fatty liver disease.

This study, called DAISy-PCOS, wants to find out which women with PCOS are most likely to develop these serious health problems. By understanding the similarities and differences in women with PCOS, the aim is to develop better ways to identify those at highest risk early on. This could help prevent conditions like type 2 diabetes, high blood pressure, fatty liver disease, and heart problems from developing later in life.

Key takeaways

PCOS affects many women and can increase risk of other health issues.
This study aims to predict future health risks in women with PCOS.
It involves questionnaires, body measurements, and blood/urine tests.
The goal is early detection and prevention of serious health problems.
Participation helps future patients, with no direct treatment in the study.

Who may be eligible?

To be considered for this study, you need to be a woman who is thought to have Polycystic Ovary Syndrome (PCOS) and be between 18 and 70 years old. You also need to be able to fully understand the study and agree to take part.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have serious kidney or liver problems. You also can't take part if you've been in another medical study recently that involved a new medicine in the last 12 weeks.

Additionally, if you've been taking certain medications, such as steroid medicines in the last six months, or other drugs that could affect hormones or your body's metabolism in the last six months, you might not be suitable. If you've used hormonal contraception like the pill or patches in the last three months, or implants in the last year, this study might not be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman who may have PCOS?
Are you between 18 and 70 years old?
Are you able to understand the study and give your consent?
Are you currently pregnant or breastfeeding? (If yes, you can't join)
Have you used hormonal contraception (pill/patch) in the last 3 months, or an implant in the last year? (If yes, you can't join)
Do you have severe kidney or liver problems? (If yes, you can't join)

Answer every question to see your result.

What does participation involve?

The study involves a few steps. You'll answer a set of questions about your symptoms and medical history. Researchers will also measure your body composition (like how much fat and muscle you have) and your blood pressure. You'll need to provide blood and urine samples. These samples will be used to look at your hormone levels, including male hormones, and thousands of other natural substances in your body. All of this information will help researchers find patterns and groups of women with PCOS. The total duration of your involvement isn't specified, but it will involve these initial assessments and sample collections.

Potential risks and benefits

By taking part, you won't directly benefit from treatment, but your information will be very valuable in helping doctors better understand PCOS and identify women at higher risk of related health issues in the future. As with any study involving blood tests, there's a small risk of discomfort, bruising, or infection at the site where blood is drawn. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Wellcome Trust Clinical Research Facility
Verified postcode
Birmingham, United Kingdom· Recruiting

Common questions

What is PCOS?

PCOS, or Polycystic Ovary Syndrome, is a common condition that affects how a woman's ovaries work. It can cause irregular periods and make it harder to get pregnant, and it's also linked to other health problems like diabetes.

Why is this study important?

This study is important because it aims to find ways to identify women with PCOS who are at the highest risk of developing other serious health conditions, such as diabetes and heart disease, so these problems can be detected and potentially prevented earlier.

Will I receive any treatment in this study?

No, this study is about understanding PCOS and identifying risks, not about giving new treatments. Your involvement will help future patients rather than provide direct treatment for you.

What kind of samples will be collected?

Researchers will collect blood and urine samples to check your hormone levels and other natural substances in your body.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Eka Melson

e.melson@bham.ac.uk +447852146611 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.