The EndoBarrier is a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery, according to UK researchers who evaluated the safety and efficacy of the a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. The paper, ‘EndoBarrier: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?’, published in Obesity Surgery, by researchers from Imperial College London, London, Southampton General Hospital Hampshire, Central Manchester University Hospitals NHS Foundation Trust, Manchester and Southmead Hospital Bristol, Bristol, UK.

The duodenal-jejunal sleeve bypass (DJSB) or EndoBarrier (GI Dynamics) is an endoscopically implantable and removable device that is anchored in the first part of the duodenum, where it is attached by a nitinol stent anchor to a 60-cm long polymer sleeve. The sleeve prevents ingested food from coming into contact with the mucosa of the proximal upper intestine. The design of the DJSB therefore offers functional similarities to mimic some of the physiological effects of Roux-en-Y gastric bypass. These include exclusion of food from the proximal small intestine and mixing of pancreatic and biliary juices after food passes through the sleeve.

This non-randomised study conducted at three investigational sites (Southampton, London and Manchester) in the UK, sought to assess the safety and efficacy of the EndoBarrier in obese patients with type 2 diabetes over an 18-month period, with a 12-month implant duration, and then six months follow-up.

In total, 45 patients were enrolled into the study; 31 patients (69%) completed the 12-month study period. Forty (of the 45) patients (88.9%) reported 127 device-related adverse events from their individual completed study period. The vast majority of patients (38 (84.4%)) experienced mild device-related events. Thirty-eight patients (84.4%) experienced at least one gastrointestinal adverse event: ten patients (22.2%) reported 12 procedure-related adverse events, seven (15.6%) of which were classified as mild including nausea, vomiting and pharyngolaryngeal pain.

Both weight and BMI were significantly reduced from baseline values with both parameters at their lowest point 12 months after insertion. The mean weight loss was 15 kg (p<0.05) 12 months after the device was inserted. Weight loss was most rapid within the first three months of insertion (baseline 115.6 ± 21.1kg (mean ± SEM), three months 106.2 ± 20.5kg; difference 9.4 kg (p=ns)).

BMI was reduced by 4.9 (p<0.005) 12 months after device insertion and by 4.6 (p<0.005) from baseline. Significant reductions in BMI from baseline to 6, 9 and 12 months were observed (mean difference 3.97 (p<0.05), 4.6 (p<0.05) and 4.90 (p<0.005) respectively). However, following explant weight increased by 2.2±5.1kg at three months and 3.1±5.2kg at six months.

HbA1c was significantly reduced from baseline values during the 12-month device insertion period. At 12 months, the mean HbA1c was 0.8% below the mean at baseline (p<0.05) and a significant reduction in HbA1c was seen as early as three months after insertion (p<0.05). This was further increased to 1.0% reduction at six months (p<0.005) and 1.2% reduction at nine months (p<0.00001).

Approximately 28% of patients taking metformin had their dose of the drug reduced or discontinued six months after device insertion, which was similar after 12 months. Approximately 28% of patients taking sulphonylureas had their dose reduced or discontinued the drug six months after device insertion. This increased to 31% after 12 months.

“Increasingly, patients and physicians are looking towards minimally invasive techniques as an alternative to conventional surgery to treat chronic diseases. The EndoBarrier is a device easily implanted and explanted without incisions, reducing complications, time, cost and recovery associated with conventional treatment modalities,” the researchers conclude. “Any measures to reduce these whilst maintaining or improving the patient treatment experience and post-procedure quality of life by the omission of surgery should be further explored. This study shows the EndoBarrier to be a safe and effective device for the treatment of obesity associated with type 2 diabetes.”

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