An Intestinal Barrier to Obesity and Diabetes
Another study of the safety and effectiveness of an intestinal barrier for treating obesity and type 2 diabetes provides further perspective on the potential usefulness of this device.
The device, sold as the EndoBarrier® in Europe, has been available there since 2010. In the U.S., it has not yet been submitted to FDA for approval to market. It’s worth noting that this device requires no surgery, just the placement of this sleeve into the small intestine with an endoscope through the mouth and down the throat.
This latest study, published in the Annals of Surgery, compares six months of therapy with the EndoBarrier plus dietary counseling to dietary counseling alone. At six months, the EndoBarrier group had lost 32% of their excess weight, compared to 16% in the control group. The active treatment group also experienced better improvement in control of their diabetes.
After six months in this trial, the device was removed and patients were followed for another six months. Not surprisingly, the differences between the active and control groups narrowed as patients in both groups regained some weight. The difference in excess weight loss remained statistically significant at the end of 12 months, but diabetes control did not.
In Europe, the EndoBarrier is now indicated for use up to 12 months. A large, sham-controlled trial is underway in the U.S. with results expected to support a submission for FDA approval in 2015.
The key questions that remain for this device are two. Will it beat a sham control in the ongoing trial? Sham procedures can show remarkable efficacy and the experience with sham-controlled trials is limited. Through no fault of the device, it’s possible that the statistical results could be disappointing.
The second — and more important question — is how the 12-month use of this device will fit into clinical practice. Will it be useful as a prelude to bariatric surgery? Or will it be more useful for intermittent therapy?
Time will tell.
“Innovation is creativity with a job to do.” — John Emmerling
Click here to read the latest study of the EndoBarrier in Annals of Surgery and here for an earlier, uncontrolled 12-month study.
Intestines, image from “The laws and mechanics of circulation, with the principle involved in animal movement” (1885) © Internet Archive Book Images / flickr
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