New Noninvasive Device Could Control Diabetes

Intestinal liner leads to significant drops in blood sugar levels, researcher says

WEDNESDAY, Sept. 17 (HealthDay News) -- Early trials of a new implantable, and removable, intestinal liner have shown promise as a noninvasive means to promote blood sugar control and weight loss.

In contrast to well-established invasive procedures like gastric bypass surgery, the application of the liner does not involve a scalpel. Rather, a doctor inserts it into a patient's small intestine through the mouth in a procedure known as endoscopy.

Once placed, it creates a physical barrier between incoming food and the intestinal wall, thereby altering the way food moves through, and gets processed by, the digestive system.

"Over the last few years, we've learned how effective bariatric surgery can be," explained study author Dr. Lee Kaplan. "But surgery is invasive, and because it has significant side effects in a small percentage of patients, it would be nice to come up with noninvasive things that can work effectively along the same principles of surgery. And this device does that."

The findings were presented Wednesday at the First World Congress on Interventional Therapies for Type 2 Diabetes, in New York City. Kaplan cited the results of extensive animal research alongside several small patient studies to indicate that the device, called the EndoBarrier Gastrointestinal Liner, appears to be effective at both quickly reducing blood glucose levels and shrinking the waistline.

"Our earlier animal data was convincing and conclusive, and proved that the concept works," he said during a news conference. "And now this preliminary work with a small group of people appears to be completely consistent with what we've seen in animals -- namely, it has a very dramatic effect in terms of improving diabetes and a good, although not quite as dramatic effect, in terms of weight loss."

Kaplan is a gastroenterologist and associate professor of medicine at Harvard Medical School, as well as director of the Massachusetts General Hospital Weight Center in Boston. He noted that he has no investment in the marketing or capitalizing of the device. However, his current research is funded by a grant from the device's Massachusetts-based manufacturer, GI Dynamics, for whom Kaplan serves as a consultant.

To indicate the enormity of public health concern over diabetes, Kaplan and his colleagues shared 2007 statistics issued by the U.S. Centers for Disease Control and Prevention, which estimate that 23.5 million Americans are diabetic, of whom 90 percent to 95 percent have type 2 diabetes.

At the meeting, Kaplan noted that 118 patients have been outfitted with the liner, in trials conducted in Chile, the Netherlands and the United States.

Today's announcement focused on the results of one of those trials, involving 18 type 2 diabetes patients, 12 of whom received the liner and six of whom received a so-called "sham endoscopy.

After tracking patients post-implant for an average of 31 weeks, the authors determined that average blood glucose levels fell approximately three to four times more steeply among patients receiving the actual implant as opposed to those who received nothing.

This findings build upon an earlier analysis of the same patient group -- announced this past June -- which indicated that blood sugar control rapidly improved post-implant in as little as one week.

At the same time, patients were found to have lost an average of 27.5 pounds by the 30-week point --an achievement described as "slightly less dramatic an effect" when compared with the device's impact on glucose levels.

However, the researchers noted that improvements in blood sugar control appeared to occur independently of weight loss --indicating that the device has a direct beneficial impact on diabetes status, regardless of how well it sloughs off the pounds.

"This is just one model of the types of endoscopic devices that we are going to see in the future," Kaplan said at the meeting, and he noted that his research team plans to launch larger, long-term trials to further explore this particular mechanism's potential.

"I'm optimistic," said Kaplan. "This is one of the more promising devices. But we're at least a few years away from FDA approval, and this is just an early development phase."

For his part, Dr. Samuel Klein, director of the Center for Human Nutrition at Washington University School of Medicine in St. Louis, agreed that more investigation is needed.

"I know the device well," he said. "And certainly the fact that we now know that the gastrointestinal tract has a profound influence on both regulating food intake as well as potentially regulating metabolic control brings gastroenterology, as well gastrointestinal devices, into the forefront of metabolic therapy."

"But whether this particular device actually works in humans is yet to be determined," Klein cautioned. "And nothing short of randomized control trials will be acceptable to determine its efficacy. That will be the proof in the pudding."

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