A two-foot wisp of plastic weighing a fraction of an ounce could become a heavyweight ally to patients struggling to subdue their obesity and dial back complications such as type 2 diabetes.
University of Colorado Anschutz Health and Wellness Center researchers, led by Holly Wyatt, MD, are part of a national trial of the EndoBarrier, a medical device made by Lexington, Mass.-based GI Dynamics, Inc. that is designed to control weight.
In the next six months, Wyatt and colleagues hope to recruit 20 adults with a combination of high body mass index (BMI) and poorly controlled diabetes to see just how well the EndoBarrier actually works. It’s the first major medical device trial the Wellness Center has hosted since opening its doors a year ago, Wyatt said.
It probably won’t be the last.
“One of our goals with the Wellness Center is to get big grants, so that when something like the EndoBarrier trial happens, people have heard about us and are seeking us out,” said James O. Hill, PhD, the Wellness Center’s executive director.
In a high-school yearbook of medical devices, the EndoBarrier would have a lock on Most Likely to Be Mistaken for a Produce-Section Baggie. Yet preliminary trials show the device to provide many of the benefits of bariatric gastric-bypass surgery at a fraction of the cost and without the need for surgery.
Using a standard endoscope, physicians place the EndoBarrier into the duodenum, just past the stomach, where a stent opens, unfurling a roughly one-inch-diameter baggie into the upper part of the small intestine. The stomach’s output flows through the tube and is sequestered from the intestinal lining until it flows out the tube’s open bottom for digestion in the remaining 20-plus feet of small intestine.
The unobtrusive device seems to afford patients outsize benefits. A small Dutch study found that three months after 22 successful EndoBarrier implantations, patients lost 19 percent of their excess weight, compared to 6.9 percent of excess weight among those who did not receive the device. More strikingly, seven of eight patients with type 2 diabetes who received the EndoBarrier enjoyed a dip in their glucose levels, hemoglobin A1c scores and medication requirements at three months. Studies in Brazil and Chile similarly have reinforced the EndoBarrier’s promise.
But clearing the U.S. Food and Drug Administration bar for approval in the United States requires a multi-center trial to establish safety and effectiveness. The Anschutz Health and Wellness Center is on the list of institutions participating in the current study, which now numbers more than 20. Investigators hope to enroll 500 patients across the investigative sites. Half will host an EndoBarrier for a year; the other half will receive a sham procedure and serve as controls. When the year is up, Wyatt said, those who did not receive the EndoBarrier will be offered one, too.
The benefits of the EndoBarrier seem to outweigh simple arithmetic. In the Dutch study, blocking 10 percent or less of the intestine brought about weight loss of close to 20 percent, and with disproportional, rapid plunges in diabetes-related numbers.
“There seems to be something in those first two feet [of the small intestine] that are critical in glucose management – something about nutrient delivery and other aspects of satiety and appetite,” Wyatt said.
Patients who receive bariatric procedures such as the Roux-en-Y gastric bypass enjoy similar benefits, Wyatt said. But the EndoBarrier leaves the stomach unobstructed while avoiding the need for surgery, she added.
Given that more than one-third of American adults are obese – that is, with a BMI of 30 or higher – the study would seem to be able to choose from a large pool of applicants (see sidebar for details). But the trial’s primary goal, besides establishing the safety of the device, is to understand the EndoBarrier’s benefits to those with diabetes. Patients who enroll must have levels of hemoglobin A1c – a measure of long-term blood-sugar control – of 8 to 10. That’s substantially higher than the goal of less than 7 points for those with controlled diabetes.
“That takes a lot of people out of the potential mix,” Wyatt said. So much so, she added, that just one in 30 who have inquired actually meet the study criteria.
Even if the trial is successful – it’s scheduled to wrap up in 2015 – questions will remain, Wyatt said. What should patients do after the device is removed? Should another EndoBarrier be inserted for another year – or longer – after a certain amount of time?
Gastric bypass and other bariatric procedures of the sort offered at UCH’s Surgical Weights Loss Center will probably retain some meaningful role in the therapy mix, Wyatt said.
“We need to match different strategies for different individuals,” she said.
Wellness-related options like the EndoBarrier could bite into the hospital’s business over time, Hill said. But promoting wellness is an increasingly vital part of the mission of both UCH and the CU School of Medicine, he added.
“We have a great system for taking care of diseases, and now we have a great system for wellness,” he said. “It only enhances us as an institution.”