EndoBarrier Device Holds Promise for the Treatment of Type 2 Diabetes and Obesity
Recently, increasing evidence has suggested that weight-loss surgery (called “bariatric surgery”) can help improve type 2 diabetes management (or even cause its reversal) regardless of the weight loss achieved. Bariatric surgery has historically been reserved as a last resort for obese people with a BMI (Body Mass Index) greater than 40 kg/m2 (e.g., 5’7”, 250 pounds) or a BMI greater than 35 kg/m2 (e.g., 5’7”, 190 pounds) with other health conditions. However, some scientists, physicians, and organizations (including the International Diabetes Federation) are now recommending that these procedures be considered in people who are less obese and have type 2 diabetes (see our NewNowNext in diaTribe #32). In particular, one of the more popular procedures performed in the US, called gastric bypass (a procedure that reduces the size of the stomach and reroutes food away from part of the intestine), has demonstrated profound improvements in type 2 diabetes, including its complete reversal in about 90% of people. However, while the potential benefits of surgery are high, so are its risks, with the possibility for long-term health consequences (such as nutritional deficiencies), reoperations, and death (roughly one of every 200 people who undergo gastric bypass die within 30 days of surgery).
Enter the EndoBarrier® Gastrointestinal Liner, a device that attempts to mimic some of the effects of gastric bypass without requiring surgery, thereby capturing some of its benefits while reducing risk. The EndoBarrier is inserted through the mouth and secured just below the stomach and into the start of the intestine. Implanting the device takes approximately 30 minutes under general anesthesia, while its retrieval takes about 15 minutes. The EndoBarrier is designed to act as a physical barrier between food and the walls of the intestine to delay digestion and bring about other hormonal improvements in metabolism. In a study in Brazil, individuals (with average BMI of 44.8 kg/m2, e.g., 5’7” and 290 pounds) with EndoBarrier implants achieved an impressive A1c reduction of 2.3% from a baseline of 8.9%. This reduction was obtained after a year of using the EndoBarrier, and it was sustained to six months after removal of the device. In another study in Chile, 12 months of EndoBarrier treatment produced an average of 20% total body weight loss (about 50lbs). Six months after removal, individuals who used the EndoBarrier maintained as much as 75% of the weight they lost during the treatment period. While the A1c-lowering effects of the EndoBarrier are encouraging, the small sample size (13 individuals) and short follow-up duration make it hard to know how effective the device will be in the long term and for less obese people with type 2 diabetes. But the high weight loss and A1c reduction could serve as an effective ‘kick start’ to a simultaneous lifestyle improvement program.
While the ease and reversibility of the procedure are preferable compared to bariatric surgery, we await more information on patient experience. Some people in the studies have reported early (usually temporary) nausea and pain caused by the expansion of the anchor that secures the liner to the intestine and (rarely) the movement of the device itself – although the overall scale and severity of side effects are much better than bariatric surgery.
The EndoBarrier has CE Mark approval in Europe for implant periods up to 12 months of use and received TGA approval in Australia. It is currently available in the UK, the Netherlands, Germany, Austria, and Chile. In the US, the FDA has approved a pilot clinical study which has yet to begin. --VW