CompletedInterventional

Effect of exercise on lipid challenged insulin resistance and cardiovascular risk markers in PolyCystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome (PCOS) is a common condition that affects how a woman's ovaries work. Many women with PCOS have insulin resistance, meaning their bodies struggle to turn sugar into energy. This can raise the risk of developing type 2 diabetes and heart problems later in life. Researchers at Hull Royal Infirmary are studying whether regular, moderate exercise can help the body handle fats and sugars better. The study is open to women aged 18 to 40, including those with PCOS and healthy volunteers of various body weights. Participants take part in an eight-week supervised exercise programme. Before and after the training, they attend two test days where doctors gently give them a nutrient fat drip or simple salt water through a vein to measure their insulin levels. The aim is to see how fitness protects long-term heart and metabolic health.

At a glance

Status

Completed

Sponsor

Hull and East Yorkshire Hospitals NHS Trust (UK)

Enrolment target

Start

17 Oct 2010

Estimated completion

01 Oct 2014

Polycystic ovary syndrome

What is this study about?

Polycystic ovary syndrome (PCOS) is a common hormonal condition. It can cause irregular periods, unwanted hair growth, and difficulty managing weight. Many women living with PCOS also experience insulin resistance. Insulin is a hormone that moves sugar from your blood into your cells for energy. When cells become resistant to insulin, sugar and fat build up in the blood, which can increase the risk of heart disease and type 2 diabetes.

Doctors believe that high amounts of fat in the blood make it harder for muscles to use insulin properly. This clinical trial is designed to test how muscles react to fat in women with PCOS compared to women without the condition. The researchers want to find out whether moderate exercise can 'train' muscles to burn fat more effectively, clearing the way for insulin to do its job.

By taking part, volunteers help researchers understand the link between exercise, body chemistry, and blood vessel health. The findings could lead to clearer, more practical exercise guidelines to help women with PCOS protect their long-term heart health and manage their symptoms without relying solely on medication.

Key takeaways

Tests whether an 8-week exercise plan improves insulin resistance and heart health in women with PCOS.
Open to women aged 18 to 40, both with PCOS and healthy volunteers.
Includes supervised moderate exercise sessions and two special hospital test days.
Helps scientists understand how muscle uses fat and sugar to protect against diabetes.
Joining is completely voluntary, and you are free to leave the trial at any point.

Who may be eligible?

This study is open to women aged 18 to 40 who have not gone through menopause. Researchers need both women diagnosed with PCOS and healthy volunteers without the condition. To ensure a fair comparison, they are looking for women with a healthy weight (BMI between 18 and 25) as well as women with a higher body weight (BMI between 26 and 40).

You cannot take part if you are pregnant, breastfeeding, or planning to become pregnant. The trial is also not suitable for anyone who already has diabetes, heart problems, or kidney, liver, or thyroid conditions. If you currently take medications that affect insulin (such as metformin) or weight loss medicines, you will not be able to join.

For safety reasons, you must be able to exercise and cannot join if you already work out three times a week. People with allergies to eggs, soya, or insulin cannot take part. Finally, you must be happy for the study team to let your GP know that you are taking part.

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.

I am a woman aged between 18 and 40 who has not reached menopause.
I have either been diagnosed with PCOS or consider myself healthy with regular periods.
I do not currently have diabetes, heart disease, or kidney problems.
I am not pregnant, breastfeeding, or trying to get pregnant.
I do not currently exercise vigorously three or more times every week.
I do not have an allergy to eggs, soya, or insulin.

Answer every question to see your result.

What does participation involve?

If you join the study, you will take part for around two to three months. You will complete an eight-week programme of supervised, moderate-intensity exercise tailored to your abilities. Before the exercise programme begins and after it finishes, you will attend two separate day visits at the research centre. During these visits, doctors place a small, flexible plastic tube (cannula) into a vein in your arm to give you either a standard salt-water fluid or a nutrition drip containing purified fats (intralipid) over five hours. Staff will take regular blood samples to check how your body responds to insulin and processes fat. The research team will support and monitor you throughout every visit.

Potential risks and benefits

Taking part may improve your physical fitness, stamina, and insulin sensitivity, which is good for your heart and overall health. However, there are some risks. Starting a new exercise routine may cause temporary muscle soreness. During the blood sugar tests, your glucose levels could dip slightly, but doctors monitor this continuously and can correct it immediately. The fat drip can occasionally cause a mild, temporary fever, and severe allergic reactions are very rare (less than 1 in 1,000). You might also experience mild bruising or tenderness where the needle is placed for blood tests. Your participation is entirely voluntary, and you can withdraw at any time without your normal NHS care being affected.

Locations (1)

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

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Unverified
Hull, England

Common questions

Do I need to have PCOS to take part in this trial?

No. The study needs both women who have PCOS and healthy volunteers without the condition so researchers can compare the results.

What is the fat drip (intralipid) and is it safe?

It is a standard medical nutrition fluid made from purified soya oil and egg components, commonly used in hospitals. It is safe and supervised by experienced doctors, but you cannot receive it if you are allergic to egg or soya.

How intense is the exercise programme?

The programme involves moderate-intensity exercise, such as brisk walking, cycling, or light gym work. It is fully supervised by trained staff to ensure it is safe and suitable for your fitness level.

Can I carry on taking my usual medicines?

Most everyday medicines are fine, but you cannot take medications that alter your insulin or blood sugar levels (such as metformin) or prescription weight-loss drugs during the study.

Will taking part cost me anything?

No, taking part is free. The study covers the costs of the exercise sessions and all medical assessments at the hospital centre.

How to find out more

Stephen Atkin

Stephen.atkin@hyms.ac.uk +44 (0)1482 675312 Official trial record

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