September 30, 2013

BARCELONA, Spain — A duodenal-jejunal bypass liner placed endoscopically in morbidly obese patients with type 2 diabetes significantly improves HbA1c levels and other metabolic parameters, according to the results of a new study.

At 12 months, HbA1c levels declined from 8.5% to 7.5% in 45 patients while weight decreased from 115 kg to 104 kg. In addition, there were improvements in fasting glucose levels, body mass index (BMI), and systolic blood pressure.

Lead investigator Julian Teare, MD, a gastroenterologist and honorary clinical senior lecturer at Imperial College London, United Kingdom,  presented the 12-month results of the study at the European Association for the Study of Diabetes (EASD) 2013 Meeting and told the audience that if someone had said 5 years ago such a concept would be effective in diabetic patients he wouldn't have believed it.

"Diabetes is now undergoing a huge change, and many other specialties are now becoming involved in the care," said Teare. "Over the course of the years, the Swedish Obesity Subjects (SOS) study showed that surgery can be incredibly effective for managing diabetes and for preventing diabetes occurring in those who are obese."

The relatively novel device, known as the Endobarrier (GI Dynamics, Lexington, Massachusetts), has been implanted in more than 500 patients in the United Kingdom and is designed to be placed only for a short period of time before removal. The concept of the Endobarrier is that the duodenal-jejunal bypass liner is inserted so that, as food leaves the stomach and passes down through the sleeve, it does not mix with bile or pancreatic juices.

In the present study, 45 patients with an average BMI of 39 kg/m2 who were currently treated with oral antidiabetic medications and insulin were treated with the Endobarrier. Immediately after the procedure, patients had their insulin and sulfonylurea doses reduced by 50% and ate a liquid diet for the following 2 to 3 weeks. After 1 year, the device was removed.

As noted, HbA1c levels were significantly reduced at 12 months. The biggest reduction occurred within the first 3 months, although there were reductions between 3 months and 1 year. In total, 35 patients had their metformin doses maintained at the time of the procedure — it was a protocol violation to reduce the metformin dose despite the implant — and these patients performed slightly better, with HbA1c levels reduced 1.2%.

"So it would seem that most of the effect is due to the device rather than any changes in metformin," said Teare.

In addition, patients lost an average of 10% of their body weight and BMI was reduced to 36.0 kg/m2. Systolic and diastolic blood pressure was reduced 6.3 and 3.2 mm Hg, respectively.

In total, there were 3 device-related removals, including 1 for melena, 1 for movement of the anchor that holds the device in place, and 1 for abdominal pain. In terms of non–device-related removals, 5 were taken out at the patient's preference at 6 months and 5 for potential bleeding risks in patients with comorbid conditions, including atrial flutter, gout requiring nonsteroidal anti-inflammatory drugs (NSAIDs), stent implantation, transient ischemic attack, and deep vein thrombosis.

A 160-patient randomized, controlled trial that will test the Endobarrier against standard medical therapy in obese subjects with type 2 diabetes is starting in 2014. The device is not approved by the US Food and Drug Administration, but is available in Australia, Chile, the United Kingdom, Germany, Austria, the Netherlands, and Israel.

Teare reports serving as a scientific advisor for GI Dynamics.

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