A plastic sleeve designed to line the small intestine to prevent the absorption of food was as good or better than bariatric surgery on a number of fronts, including controlling the symptoms of diabetes, according to a trio of recent studies.
The EndoBarrier, made by Lexington, Mass.-based GI Dynamics, gave subjects in one small trial "rapid and long-lasting improvement in diabetes" and "demonstrated beneficial hormonal effects similar to surgical interventions such as Roux-en-Y gastric bypass."
"The effect on diabetes is in the same order of magnitude if not equal to bariatric surgery," Dr. Lee Kaplan, director of the Weight Center at Mass. General Hospital and an associate professor at Harvard Medical School, told MassDevice. "There really is no other non-surgical approach that I’m aware of that compares."
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Kaplan, who is on the GI Dynamics scientific advistory board and was paid by the company to run pre-clinical, animal tests of the device but holds no stock, told us that about 400 EndoBarriers have been implaned worldwide, about 10 of those in the U.S. He cautioned that these early study results, though positive, need to be followed by much larger studies evaluating the device’s safety.
"That doesn’t mean that this is a panacea," Kaplan said. "We need to see larger studies on safety and serial implantation. … My guess is that we’ll have information from a pivotal study over the course of the next few years."
In one 17-subject study, presented this week at the 2nd World Congress on Interventional Therapies for Type II Diabetes in New York, obese patients implanted with the device showed a rapid and sustained increase in insulin sensitivity and higher levels of two hormones involved in Tyupe II diabetes. The mean excess weight loss among that cohort was 29.8 percent after six months. Kaplan said the results "provides first evidence of a molecular mechanism" triggered by the device that helps regulate Type II diabetes.
"The device has effects that are, in many ways, similar to gastric bypass. Both cause weight loss and eating less," he explained. "It’s evidence that [the EndoBarrier] causes effects on diabetes that are out of proportion to the effects of eating less and losing weight."
Further study may also reveal other benefits, Kaplan added, including allowing a pancreas overtaxed by diabetes to take a break.
"With respect to diabetes, the theory is that they’re ‘resting’ the pancreas, giving it a chance to regenerate," he said, speculating that periodic rest periods "could turn the clock back by a number of years" in the progession of diabetes.
And for the children of pregnant women with diabetes, the benefits could be life-long. Those children often wind up developing diabetes themselves if the mother’s diabetes isn’t under control during the pregnancy.
"If their diabetes is controlled, it could reduce or eliminate the risk of diabetes for the child," Kaplan said.