Patients battling obesity and Type 2 diabetes will sometimes go to great lengths to reduce the amount of food reaching their bloodstream, including having their gastrointestinal tracts rearranged in a procedure known as gastric bypass. But GI Dynamics may soon be able to offer a less drastic alternative—a two-foot-long flexible sleeve slipped into the GI tract to provide a barrier between food and a segment of the small intestine. Today, the Lexington, MA-based company is reporting that, in a small study, its noninvasive device was able to significantly reduce blood diabetics’ blood-sugar levels, while also helping them lose weight.
The results are being presented today at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York City. In the study, researchers randomly assigned 18 patients to be fitted with GI Dynamics’ EndoBarrier device—which is inserted through the mouth in an endoscopic procedure—or to undergo a sham version of the procedure. Patients receiving the gut-lining device had their blood sugar levels reduced by three times as much as would be considered clinically significant, Kaplan says. They also lost an average of 27.5 pounds after about seven months.
The finding of reduced blood sugar is “extraordinary,” says Lee Kaplan, an associate professor of medicine at Harvard Medical School and director of the Weight Center at Massachusetts General Hospital, who is presenting the results today. The weight loss that patients experienced in the study wasn’t as compelling as that seen with alternatives like gastric bypass surgery, he says, but such more invasive procedures might carry more risk. Not only is the procedure to insert the GI Dynamics device a minimally invasive one, it’s also reversible—the device can be retrieved via the mouth.
If the EndoBarrier’s benefits are proven in further studies, the devices could offer a new treatment option for some of the estimated 23.5 million U.S. adults with diabetes.
“These are the most exciting and promising device data I’ve seen from endoscopic devices,” Kaplan says.
But there are still plenty of unanswered questions, Kaplan says. Doctors will want to know if the pliable, plastic-like device will stay put over long periods of time, and whether it will irritate the gut or cause ulcers or bleeding. It’s not likely to cause nutritional deficiencies, because food can still be absorbed in the remaining 18 feet of intestine that the EndoBarrier doesn’t cover, Kaplan says. Still, iron is one mineral that tends to get absorbed in the segment of the gut covered by the device, so patients may need iron supplements to stave off anemia.
So far, GI Dynamics’ device is stacking up favorably to other endoscopic devices in early testing, like Palo Alto, CA-based Satiety’s TOGA system, or St. Paul, MN-based EnteroMedics’ VBLOC Therapy, Kaplan says. GI Dynamics plans to run a larger, longer-term study with an enhanced device in 2009, so Kaplan and his colleagues will soon get a better idea whether EndoBarrier is the real deal.
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