Surgeons in Southampton are set to discover if a pioneering ‘sleeve’ implant could be more effective at treating type 2 diabetes than medication, diet and exercise.
The small device, known as EndoBarrier, is placed into the small intestine via the mouth for up to 12 months and is made from fluoropolymer, a material known for its high resistance to acids.
It acts as a barrier to prevent food being absorbed and ensures it bypasses a section of the upper intestine, allowing less time for digestion and improving the resistance to insulin.
In a 24-month study involving 160 participants, experts at Imperial College Healthcare NHS Trust and Southampton General Hospital, will compare EndoBarrier with standard medical therapy for the management of obese people with type 2 diabetes.
The procedure, which was trialled on adult patients in a pilot study at Southampton General Hospital and two other NHS sites in 2011, is performed under a short general anaesthetic and sees patients return home within two to three hours.
Results of that study showed a drop in blood glucose levels within weeks of receiving the implant – reducing the need for diabetes medication – while patients also achieved significant weight loss similar to that seen following gastric band surgery.
Professor Julian Teare, a consultant gastroenterologist and study lead based at Imperial College London, said: “Type 2 diabetes affects millions of people in the UK and many of these people have been unsuccessful at managing their diabetes with their current treatment regimens.
“While previous clinical trials and commercial experience suggest that EndoBarrier therapy is a safe and effective treatment option for type 2 diabetes, results from this study should provide definitive evidence to help guide treatment decisions.
“The use of a lower cost and less invasive alternative to bypass surgery may mean we can treat thousands more people living with type 2 diabetes every year.”
Mr James Byrne, a consultant surgeon and co-lead based at Southampton General, added: “We know weight loss surgery is currently the most effective and longest-lasting treatment option for type 2 diabetes.
“However, it is not the right approach for everyone and will not significantly impact the epidemic of type 2 diabetes we see in the UK.
“Other strategies for this condition are urgently required and our research will confirm whether or not EndoBarrier therapy can help to deliver and, more importantly, sustain improvements in diabetes control.”
In a clinical study in 2012, a team led by Mr Byrne and Dr Nikki Davis, a consultant paediatric endocrinologist at Southampton General Hospital, became the first in the world to treat a teenager with type 2 diabetes using the EndoBarrier device.
For more information on the study, funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership, visit www.uhs.nhs.uk/endobarrier.
Posted on Monday 15 June 2015