Combined diabetes and obesity, 'diabesity', is a serious health problem with considerably increased risks of premature heart attack, stroke and death. If not controlled, it can also affect the eyes leading to blindness, the kidneys leading to kidney failure and the feet leading to ulcers and amputation.
The number of patients with diabesity is increasing rapidly, both in the UK and world-wide. Despite all the available expertise and best use of the most modern treatments there are many patients who remain considerably overweight and with poor diabetes control, rendering them vulnerable to these complications.
For such patients a possible new treatment has become available. It is called endobarrier and consists of a 60cm tube-like liner made from a thin, flexible and durable impermeable polymer. It is inserted by the simple procedure of endoscopy and is anchored in place, just beyond the stomach, by a basket of very thin wire made of Nitinol-an alloy of nickel and titanium. The endobarrier prevents food from contacting the first two feet of small intestine and this leads to considerable weight loss (18% reduction) and improvement in diabetes control (87% of patients reach the target control level).
Because this treatment could well be just what is needed for the patients who remain in trouble from their diabetes despite the best treatments available, ABCD have initiated a national trial of the new device funded by a grant from their Diabetes Care Trust (ABCD ) Registered Charity Number 1139057. The study is supported by the NHS and is centred at Birmingham's City Hospital with supporting centres in London (King's College Hospital and Guy's and St Thomas' Hospitals) and Glasgow (Glasgow Royal Infirmary).
Dr Piya Sen Gupta, ABCD Research Fellow, who is conducting the study for ABCD, said: "This trial presents an exciting opportunity for patients with combined diabetes and weight problems, who currently have limited treatment options, to kick start their way back to health.
"It is a novel idea to use a device to treat diabesity when the usual medications have failed and it may offer a valuable treatment option, avoiding in some, the need for invasive bariatric surgery. By opening this study up to NHS patients in Birmingham, London and Glasgow, the results will be relevant throughout the UK. This study has been so named, as we do hope that it goes some way to REVISE-Diabesity"
The first patient to receive the new treatment in the trial is due to have her device inserted on the morning of Thursday 25th July, 2013, at Birmingham's City Hospital.
ABCD Chairman, Dr Chris Walton, said :"The twin epidemics of obesity and diabetes may bankrupt our healthcare systems. The projected spend on diabetes rises from the current 10% of NHS expenditure to 17% of NHS expenditure by 2035 and it is estimated that, for type 2 diabetes, the cost of complications of the disease is more than threefold the cost of treatment. ABCD is keen to research new technologies that confront obesity in diabetes and which may prevent the relentless progress to complications, so the placement of the first endobarrier device in this study is a landmark date''
Dr Bob Ryder, Principal Investigator for the ABCD study, said: "At the moment we have many patients who remain overweight and with poor diabetes control, despite all the available diabetes treatments. Because the endobarrier reduces weight and improves the diabetes control, it is a treatment that could break the cycle of problems for these patients who have otherwise come to the end of the line.
"The best thing about the endobarrier is that it is not permanent and after insertion at endoscopy, it is removed up to a year later, and we then have to hope that the improvement is sustained. This treatment is not currently an NHS treatment, but this is an NHS approved study, and if the trial proves successful and cost effective, we expect that the device will be considered by NICE for approval as part of mainstream NHS diabetes treatment in the future".