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Author: Louise Stanley

New clinical trial aims to improve heart protection during surgery in children

Written by Louise Stanley on . Posted in Clinical trials.

A new clinical trial being led by BHP founder-member the University of Birmingham and funded by the British Heart Foundation could help improve the recovery of children who undergo life-saving heart surgery.

The £570,000 study will compare two ways of protecting the heart when children require open heart surgery to repair congenital heart defects, to find which is most effective.

Congenital heart disease is a heart defect that develops in the womb before a baby is born. Each day in the UK, around 13 babies are diagnosed with a congenital heart condition, with more diagnoses later in life.

In severe cases, and often at a young age, open heart surgery is required to repair the defect to help improve the child’s survival and quality of life. Some children require multiple operations, and recovery from open heart surgery can take several weeks or even months.

During open heart surgery, a fluid called cardioplegia is commonly used to stop the heart beating so that the surgeon can repair it safely. Although the technique is safe, cardioplegia stops the blood flow to the heart and may cause damage to the heart muscle when the blood flow is restored, which can affect the child’s recovery.

There are many different types of cardioplegia solutions available, which work in slightly different ways – and it is not currently known which fluid works best in children of different ages.

In the United States, the most commonly used solution is called del Nido cardioplegia, which was designed specifically for use in children’s heart surgery but has not previously been available in the UK.

The new trial will compare del Nido cardioplegia with St Thomas’ cardioplegia, which has been used for many years in both adults and children and is currently the standard of care in the UK.

It will involve 220 children undergoing open heart surgery at four hospitals across the UK – Birmingham Children’s Hospital, Bristol Royal Hospital for Children, Great Ormond Street Hospital and Leeds Children’s Hospital.

Half of the patients will be assigned to receive del Nido, with the other half receiving St Thomas’ cardioplegia. Researchers will then compare the two groups by assessing how well the children recover from surgery and determining the extent of any heart damage.

The study will help to reveal whether one solution is potentially more effective than the other for children during surgery.

The research will be led by Nigel Drury, Consultant in Paediatric Cardiac Surgery at BHP member Birmingham Children’s Hospital and Hunterian Professor in the Institute of Cardiovascular Sciences at the University of Birmingham.

Mr Drury, who is also a British Heart Foundation (BHF) Intermediate Fellow, said: “By improving the way in which we protect the heart during surgery, we expect that children will recover from surgery faster and with fewer complications.

“These early benefits may also lead to better long-term outcomes, with less injury and scarring to the heart muscle. As children with severe heart defects often need multiple operations, they will have the most to gain from improving how we protect the heart during each surgery.

“If our trial is successful, this will support the need for a larger, definitive study, which could have the potential to change the way children are treated around the world.”

Dr Shannon Amoils, Senior Research Advisor at the British Heart Foundation, said: “Heart defects are the most common congenital anomaly in babies born in the UK, so it’s important that we continue to refine treatments for these conditions to help improve the lives of young patients.

“This multi-centre trial, held at four leading UK children’s hospitals, will compare how well these two solutions can protect the hearts of children undergoing open heart surgery. If the study reveals important differences between the two solutions, a larger clinical trial would be needed to further investigate the findings. Ultimately, this important research could result in heart surgery becoming even safer for children.

“The BHF can only fund vital research like this thanks to the generous support of the public, in driving forward our mission to beat heartbreak forever.”

Alfie Donnelly, aged nine and from Erdington, was born with various complex congenital heart diseases and has had to undergo three open heart surgeries at Birmingham Children’s Hospital.

Mum Claire Donnelly, aged 43, said: “When Alfie was a new-born, we noticed that he wasn’t feeding well, was cold all the time and wouldn’t cry. We struggled to wake him one morning and he was making a grunting noise when he was breathing, so I rang the hospital who told us to bring him in.

“Alfie became so ill that he was put on a life support machine. After several tests and scans, we were told that Alfie’s heart condition was rare and complex and that he needed open heart surgery. We were also told that if a procedure did go ahead, it was unlikely he would survive past his first birthday. The whole situation felt so bizarre, I remember feeling frozen to the spot.

“Alfie was just one week old when he had his first operation, and he was a little fighter. He has since had two more open heart surgeries, which included replacing the damaged valve in his heart with a donor valve.

“Alfie’s recovery after surgery has been slow and he has had further complications. Following his first and second surgery, Alfie had a build up of fluid in his lungs and this required several chest drains, which meant spending further time in hospital.

“With what Alfie has been through, it has made us a solid family and we all appreciate life even more. For us as a family, the research that the BHF is funding gives us hope that children and babies with congenital heart disease, like Alfie, aren’t being forgotten. So much more is needed to raise awareness of heart defects in children.”

Researchers awarded vital funding to explore treatment to slow rare liver disease

Written by Louise Stanley on . Posted in Clinical trials.

LifeArc and PSC Support have jointly awarded £948,774 for new research into primary sclerosing cholangitis (PSC) – a rare disease where the body attacks its own liver, causing inflammation and scarring of the bile ducts.

The national study, led by Dr Palak Trivedi at BHP founder-member the University of Birmingham, is called FAecal microbiota transplantation in primaRy sclerosinG chOlangitis: The FARGO trial. The aim of the study is to explore the potential of a new treatment to slow the progression of PSC and improve the quality of life for patients.

PSC is a rare liver disease where the body attacks itself, causing inflammation and scarring of the bile ducts and liver. This causes bile to stop flowing properly, leading to repeated infections, liver failure and, in some cases, cancer. In 80% of people with PSC the body will also attack the bowel, which can lead to inflammatory bowel disease (IBD).

The combination of the two conditions results in a 15-30% lifetime risk of bowel cancer, and patients require a colonoscopy every year to look for this complication. PSC affects approximately 3,600 people in the UK. The condition can develop at any age, but has a particular impact in people under 40 years.

At present, the treatment of PSC is focused on managing the symptoms, not treating the cause. Unfortunately, there is no cure, nor any medication that has been shown to improve survival. Liver transplantation is the only lifesaving treatment. Although a very rare disease, PSC accounts for 10-15% of all liver transplants performed in the UK and is now the leading reason for transplantation in several European countries.

Transplantation is risky and costs around £1m per patient (including aftercare). Moreover, PSC returns in around 30% of people who have had a liver transplant.

The team, led by researchers at the University of Birmingham, has one of the largest PSC research programmes globally, with a dedicated PSC-IBD clinic as part of the Centre for Rare Diseases. The research team is partnering with PSC Support, the leading patient organisation for people living with primary sclerosing cholangitis, which has a wealth of experience working with medicines’ regulators on drug development for this condition.

Through this partnership the team aims to explore the potential of a new treatment to slow the progression of PSC and improve the quality of life for patients.

It has been shown that the makeup of gut microorganisms in PSC are different to that found in people without liver and bowel inflammation, and that this is associated with many abnormal immune functions, which may be a driver of disease development. The Birmingham research team will trial a novel treatment called faecal microbiota transplantation (FMT), which involves taking stool from the gut of healthy donors, refining it in a laboratory, and transferring contents to the bowel of people with PSC to reverse the imbalance of gut microorganisms.

Early research has shown that FMT is effective and safe in treating IBD. This grant, which is jointly awarded by the LifeArc philanthropic fund and PSC Support, will enable the team to accelerate and scale up their research to answer the key questions that will allow them to translate this experimental treatment, from idea to direct patient benefit across the UK PSC population.

Dr Trivedi, Associate Professor and Consultant Hepatologist at the NIHR Birmingham BRC said: “LifeArc is a self-financing charity that advances promising life science ideas into life-changing solutions for patients, particularly those living with a rare disease. I am delighted that they have chosen to support such a novel, bespoke and distinctive clinical trial, alongside the necessary translational work needed to better understand how PSC develops and progresses.

“We will test the safety and long-term effects of FMT to treat people with PSC. In parallel, this study will really help us to understand which specific consortia of gut microbes are most important, and how this information can be used to enhance the product for large scale rollout.”

Researchers will randomly allocate individuals with PSC to receive either FMT once a week for 8 weeks (group 1), or placebo (an inactive FMT equivalent; group 2). Each group will continue to receive routine standard of care for symptoms and treatment for their IBD.

Both groups will be observed for another 40 weeks, meaning the trial will run for 48 weeks. The team will then measure how successful the treatment has been in improving liver blood test results, the burden of scarring in the liver, activity of IBD and quality of life.

“Our study will lay the foundation for future work on a larger scale, with a view to making FMT available on a more global scale,” added Dr Trivedi. “In parallel, PSC Support will work with the wider study team, to support delivery of FMT as a treatment after the trial has finished.

“This will include writing and submitting the necessary trial documents to the UK medicines’ regulatory agency (the MHRA), which is a necessary step to broaden access to new treatments for people living with the disease.

“Should our trial deliver a positive efficacy signal, then PSC Support are ready to lead the conversation and advocate for patients to access FMT as early as possible. We expect patient benefit within 5-7 years after completion of this work and are working with the University of Birmingham Enterprise and Drug Discovery teams to achieve this goal.”

Birmingham research shapes new miscarriage guidelines

Written by Louise Stanley on . Posted in Clinical trials, Maternal health.

Research led by BHP founder-member the University of Birmingham has helped to shape guidelines which could mean thousands of women with prior miscarriage, and bleeding in early pregnancy, could be eligible for treatment with progesterone each year.

The updated guidance, announced today by the National Institute for Health and Care Excellence (NICE), follows a review of evidence by NICE’s independent guideline committee. The key evidence came from two trials – PRISM and PROMISE – led by the University of Birmingham in collaboration with Tommy’s National Centre for Miscarriage Research.

The results of the clinical trials, published in January 2020, evidenced both the clinical and economic advantages of giving a course of self-administered twice daily progesterone pessaries to women with prior miscarriage from when they first present with early pregnancy bleeding up until 16 weeks of pregnancy. In such women, the treatment reduces miscarriage risk and increases livebirth chances.

NICE’s updated guidance – ‘Ectopic pregnancy and miscarriage: diagnosis and initial management’ – recommends offering progesterone to women who have early pregnancy bleeding and who have previously had a miscarriage.  An ultrasound scan should be performed in these women, and if a fetal heartbeat is confirmed, NICE’s new guidelines recommend treatment with progesterone should continue until 16 weeks of pregnancy have been completed.  NICE’s independent guideline committee found that there was no evidence of benefit in women with early pregnancy bleeding but no previous miscarriage, nor in women with previous miscarriage but no early pregnancy bleeding in the current pregnancy.

Progesterone is a hormone that is naturally secreted by the ovaries and placenta in early pregnancy and is vital to the attainment and maintenance of healthy pregnancies.

PROMISE studied 836 women with unexplained recurrent miscarriages at 45 hospitals in the UK and the Netherlands, and found a 3% higher live birth rate with progesterone, but with substantial statistical uncertainty.

PRISM studied 4,153 women with early pregnancy bleeding at 48 hospitals in the UK and found there was a 5% increase in the number of babies born to those who were given progesterone who had previously had one or more miscarriages compared to those given a placebo. The benefit was even greater for the women who had previous ‘recurrent miscarriages’ (i.e., three or more miscarriages) – with a 15% increase in the live birth rate in the progesterone group compared to the placebo group.

Of the newly updated NICE guidance, Arri Coomarasamy, Professor of Gynaecology & Reproductive Medicine at the University of Birmingham and Director of Tommy’s National Centre for Miscarriage Research who led the PRISM and PROMISE trials, said: “After many years researching the use of progesterone and working to make treatment more accessible, today’s new miscarriage care guidelines from NICE include a very welcome change. Our research has shown that progesterone is an effective and safe treatment option, which could prevent 8,450 miscarriages a year in the UK – but we know it’s not yet reaching everyone who might benefit. This recommendation from NICE is an important step in tackling the current variation in miscarriage services across the country and preventing these losses wherever possible.”

Tommy’s CEO Jane Brewin said: “It’s great to see NICE taking our progesterone research on board in their new miscarriage care guidelines, which will help save babies’ lives and spare parents’ heartache. Miscarriage is often dismissed as ‘one of those things’ we can’t do anything about – even by some healthcare professionals, who may not specialise in this area to know the latest evidence. We hear from women who were denied progesterone treatment when they should have been eligible, simply because their doctor wasn’t familiar with it, so we hope NICE’s recommendation will help end some of these inequalities in miscarriage care that add more pain to an already unbearable experience.”

Meanwhile, Professor Coomarasamy was among the leading authors to lay bare the devastating impact of miscarriage and set out a raft of recommendations to improve treatment and care in a series of three research papers published in The Lancet in April 2021.

Amongst the calls to action by the research team was for urgent changes to NHS policy, which currently provides exploratory testing for underlying causes of miscarriage for women only after they have experienced three consecutive miscarriages.  The team says many of the risks related to a miscarriage are present even after one or two miscarriages, and appropriate care should be provided to all women who have experienced one or more miscarriages.

The Lancet ‘Miscarriage Matters’ series of papers formed part of a campaign by charity Tommy’s, including a petition to improve miscarriage care which has been signed by almost 230,000 supporters.

Tommy’s National Centre for Miscarriage Research has also been working with the Royal College of Obstetricians and Gynaecologists (RCOG) to share the knowledge and recommendations from The Lancet research.  Now, RCOG has updated its miscarriage care guidelines taking The Lancet papers on board and encourages the NHS to adopt a graded model of care so that parents can get support after every loss and earlier access to specialist tests and treatments.

In the revised guidelines, RCOG suggest that ‘recurrent miscarriage’ should be redefined so that losses don’t have to happen in a row for parents to receive support. Instead, they encourage doctors to use their discretion after two miscarriages if they suspect an issue might be causing the losses, and state that non-consecutive losses or those with different partners should still be treated as recurrent miscarriage.

Meanwhile, in June this year Olivia Blake MP delivered Tommy’s petition to an Adjournment Debate in Parliament in support of the campaign, which led to the then Minister for Mental Health, Suicide Prevention and Patient Safety, Nadine Dorries MP, announcing that the Government would incorporate a number of the recommendations into the Women’s Health Strategy which will aim to improve the health and wellbeing of women across the country.

Since then, Tommy’s CEO Jane Brewin has written a joint letter with Olivia Blake to new Health Minister Gillian Keegan MP, asking her to uphold Nadine Dorries’ promises in Parliament and meet with Tommy’s to discuss what happens next to make good miscarriage care widely and fairly available for everyone.

Professor Coomarasamy said: “As we work to open the ‘black box’ of miscarriage in the hope of unpicking its causes and finding new therapies, the UK must change its approach to miscarriage care, not only to reduce the risk wherever possible but also to better support those who do tragically lose their babies.”

Tommy’s CEO Jane Brewin said: “The right care can reduce the risk of miscarriage, and the right support can help parents if they experience loss – but that help isn’t reaching everyone across the UK after every miscarriage; this can and must change.

“It’s great to see the Royal College taking forward Tommy’s recommendations from our Lancet research in their new care guidelines, so we can prevent more losses wherever possible but also better support those who do sadly lose their babies. We know what to do and how to do it, so now we need a commitment across the NHS to develop these care pathways and improve support for everyone.”

In addition to the recommendations on tests and treatments for miscarriage, RCOG has also highlighted where research and evidence is lacking. This includes the health disparities facing women from Black, Asian or minority ethnic backgrounds, who were found to be at higher risk of having a miscarriage than White women in The Lancet research series. Researchers at the University of Birmingham have already begun work in this area, in partnership with Tommy’s National Centre for Miscarriage Research.

An estimated 23 million miscarriages occur every year worldwide – equating to 44 pregnancy losses each minute.  Miscarriage (defined as the loss of a pregnancy before 24 weeks) costs the UK at least £471 million a year due to direct impact on health services and lost productivity. However, scientists expect costs surpass £1 billion per year when factoring in longer-term physical, reproductive and mental health impacts.

Skull model

New programme to train future mental health and neuroscience professionals

Written by Louise Stanley on . Posted in Mental health.

Future healthcare professionals working in mental health and neurosciences will be trained at a new Doctoral Training Programme (DTP) thanks to a multi-million award from Wellcome.

Led by the University of Nottingham, the new DTP is a collaboration between the Universities of Nottingham, Leicester, Birmingham and Warwick.

Wellcome has awarded over £7.24 million to the University of Nottingham to establish the Midlands Mental Health and Neurosciences PhD Programme for Healthcare Professionals which will begin its training programme in October 2022. The unique partnership will lead the innovative multidisciplinary training centre that will develop the next generation of NHS research leaders across the workforce.

The centre will also be supported by a number of NHS Trusts in the Midlands including BHP member Birmingham Women’s and Children’s NHS Foundation Trust, as well as Birmingham and Solihull Mental Health NHS Foundation Trust; Coventry and Warwickshire Partnership NHS Trust; University Hospitals of Leicester NHS Trust; Leicestershire Partnership NHS Trust; Nottinghamshire Healthcare NHS Foundations Trust and Nottingham University Hospitals NHS Trust.

Through 25 PhD scholarships focused on mental health (MH) and neurosciences (N), students will have the opportunity to research a ‘theme’ representing the lifespan (children, young people and perinatal MH; common MH; severe MH; dementia; and physical health comorbidity with MH), using specific bio-psycho-social approaches.

Healthcare profession-specific mentors will ensure scholars remain connected to their primary professional groups. Scholars will leave the programme as well-rounded clinical-academics with high-levels of MH&N research acumen, and enhanced communication and leadership skills.

Professor Roshan das Nair from the School of Medicine at the University of Nottingham and the Institute of Mental Health, is Director of the Centre. He said: “We are absolutely delighted to have won this award, which is a huge achievement for our four universities and the NHS Trusts with whom we work, and is a testament to teamwork. Our Doctoral Training Programme will advance the mental health and neuroscience research we conduct here in the Midlands.

“This award will enable us to share the excellent resources we have across the partner universities and NHS Trusts to develop the next generation of multidisciplinary clinical academics in mental health and neurosciences, and support their research. Our Doctoral Training Programme will create an ambitious Midlands-based, internationally connected, clinical-academic ecosystem. Through our collaborations, we hope to address the key contemporary mental health challenges our societies face.”

Professor Matthew Broome, Director of the Institute for Mental Health at the University of Birmingham, said: “Our population in the Midlands suffers from significant health inequalities, with high rates of mental health challenges. This training centre is a huge opportunity to address these challenges, increase our research capacity in mental health and neuroscience, and develop a diverse group of clinical academics from a wide range of professional groups, including nursing, social work, occupational therapy, pharmacy, medicine, and psychology.”

New drug treatment regimen shows promise for patients with lupus

Written by Louise Stanley on . Posted in Clinical trials, Inflammation and chronic disease.

The results of a randomised controlled trial, published in Annals of Internal Medicine, found that a new drug treatment regimen – using belimumab soon after rituximab – reduced a disease-related autoantibody and severe disease flares in lupus patients.

Systemic lupus erythematosus (SLE or lupus) is a long-term autoimmune condition, causing a variety of problems including joint pain, skin rashes, kidney disease and tiredness. While there is no known cure for this debilitating disease, the BEAT-Lupus clinical trial found that the combination of belimumab and rituximab shows promising results; reducing severe lupus flares by 3-fold for patients who had persistent, severe lupus disease requiring rituximab therapy at the beginning of the study.

Senior author Professor Caroline Gordon, Emeritus Professor of Rheumatology and member of the Institute of Inflammation and Ageing’s Rheumatology Research Group, together with colleagues from University College London conducted a phase 2 randomised trial involving 52 patients with SLE that was refractory to conventional treatment and whose physicians had recommended rituximab therapy. Patients were treated with rituximab and then randomly assigned four to eight weeks later to receive intravenous belimumab or placebo for 52 weeks.

The researchers found that IgG anti-dsDNA antibody levels were lower in belimumab-treated patients at 52 weeks compared with placebo-treated patients (geometric mean, 47 versus 103 IU/mL; 70% greater reduction from baseline). The risk for severe flare was reduced significantly with belimumab versus placebo (hazard ratio, 0.27), with three and 10 severe flares in the belimumab and placebo groups, respectively. There was no increase seen in the incidence of serious adverse events in the belimumab group.

Professor Michael Ehrenstein, Chief Investigator of the BEAT-Lupus trial, said: “Thanks to the dedication of the lupus teams at participating hospitals we are delighted to not only have completed recruitment, but also to provide preliminary evidence for a clinical benefit of the combination of rituximab and belimumab, compared to patients treated with rituximab alone.”

“These findings support further exploration of belimumab after rituximab as the first combination biologic therapy for patients with SLE, at least in those whose disease is refractory to conventional therapy and/or requires high corticosteroid dosages,” the authors write.

Professor Gordon previously pioneered the methodology for assessing lupus disease activity and flares using the BILAG-2004 index. The main secondary clinical outcome of reduction of severe lupus flare in the BEAT-Lupus trial was based on this work, and flare was defined using this index.

She explained: “We were delighted to find that this treatment regimen not only reduced disease causing autoantibodies but also reduced severe flares which cause very distressing symptoms and disruption to patients’ lives. This study offers the hope that this combination of drugs will be useful in the future if the results are confirmed in a larger trial.”

The study was funded primarily by Versus Arthritis; GlaxoSmithKline provided belimumab free of charge, as well as some additional funding.

Contraceptive pill can reduce type 2 diabetes risk in women with polycystic ovary syndrome

Written by Louise Stanley on . Posted in Inflammation and chronic disease.

A study led by BHP founder-member the University of Birmingham has revealed for the first time that the contraceptive pill can reduce the risk of type 2 diabetes by over a quarter in women with polycystic ovary syndrome (PCOS).

The research findings also show that women with PCOS have twice the risk of developing type 2 diabetes or pre-diabetes (dysglycemia) – highlighting the urgent need to find treatments to reduce this risk.

In addition to the risk of type 2 diabetes, PCOS – which affects 10% of women world-wide – is also associated with a number of other conditions in the long-term, such as endometrial cancer, cardiovascular disease, and non-alcohol related fatty liver disease (NAFLD).

Symptoms of PCOS include irregular periods or no periods at all, which can lead to fertility issues, and many suffer from unwanted hair growth (known as ‘hirsutism’) on the face or body, hair loss on the scalp, and oily skin or acne. These symptoms are caused by high levels of hormones called androgens in the blood of women with PCOS.

Women with PCOS also often struggle with weight gain and the cells in their body are often less responsive to insulin – the hormone that allows the body to absorb glucose (blood sugar) into the cells for energy. This reduced response to insulin can lead to elevated blood glucose levels and can cause the body to make more insulin, which in turn causes the body to make more androgens. The androgens further increase insulin levels – driving a vicious circle.

The University of Birmingham-led team of scientists carried out two studies to firstly identify the risk of developing type 2 diabetes and pre-diabetes in women with PCOS, and secondly to investigate the impact of the use of combined oral contraceptives, often referred to as ‘the pill’, on the risk of type 2 diabetes and pre-diabetes in women with PCOS. The pill is often given to women with PCOS to improve the regularity of menstrual bleeds.

Using UK patient GP records of 64,051 women with PCOS and 123,545 matched control women without PCOS, they first carried out a large population-based cohort study to analyse the risk of type 2 diabetes and pre-diabetes. They found that women with PCOS were twice at risk of type 2 diabetes or pre-diabetes, compared to those without PCOS. They also identified hirsutism (excessive hair growth) – a clinical sign of high androgen levels – as a significant risk factor for type 2 diabetes and pre-diabetes among women with PCOS.

To investigate the impact of the pill on type 2 diabetes or pre-diabetes, the researchers, including experts at the RCSI University of Medicine and Health Sciences, then carried out a further nested case control study of 4,814 women with PCOS. The scientists found that use of combined oral contraceptives reduced the odds of developing type 2 diabetes and pre-diabetes in women with PCOS by 26%.

The researchers behind the study, published in Diabetes Care, are now planning to carry out a clinical trial to further evidence their findings in the hope it will lead to changes in global healthcare policy.

Co-senior author Professor Wiebke Arlt, Director of the University of Birmingham’s Institute of Metabolism and Systems Research, said: “We knew from previous, smaller studies, that women with PCOS have an increased risk of type 2 diabetes. However, what is important about our research is that we have been able to provide new evidence from a very large population-based study to show for the very first time that we have a potential treatment option – combined oral contraceptives – to prevent this very serious health risk.”

Joint first author Dr Michael O’Reilly, Health Research Board Emerging Clinician Scientist and Clinical Associate Professor at RCSI University of Medicine and Health Sciences, added: “We hypothesise that the pill reduces the risk of diabetes by dampening the action of androgens. How does this work? The pill contains oestrogens which increase a protein in the blood called sex hormone-binding globin (SHBG). SHBG binds androgens and, thereby, renders them inactive. Thus, if the pill is taken, SHBG increases. This decreases the amount of unbound, active androgens, lowering their impact on insulin and diabetes risk.”

Joint first author Anuradhaa Subramanian, also of the University of Birmingham, added: “With one in 10 women living with PCOS, which is a life-long metabolic disorder, it is incredibly important that we find ways of reducing its associated health risks.”

Co-senior author Krish Nirantharakumar, Professor in Health Data Science and Public Health at the University of Birmingham’s Institute of Applied Health Research, added: “Importantly, our data highlight that normal weight women with PCOS were also at increased risk of type 2 diabetes and pre-diabetes. This parallels our previous finding of increased NAFLD risk in normal weight women with PCOS, further challenging the notion that PCOS-related metabolic complications are only relevant in the context of obesity. These data suggest that, rather than obesity in isolation, PCOS-specific factors, including androgen excess, underpin the increased metabolic risk.”

The study was supported by funding from Health Data Research UK, Wellcome Trust, the Health Research Board, and the National Institute for Health Research Birmingham Biomedical Research Centre which is based at BHP founding members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust.

The research was also carried out in collaboration with the University of Colombo in Sri Lanka, and McGill University in Canada.