A non-surgical “sleeve” placed in the upper intestines can effectively regulate absorpton of carbohydrates from food, reducing the buildup of sugar on red blood cells in people with Type 2 diabetes, according to interim results of clinical testing presented Monday at a gastroenterology conference in London.
The EndoBarrier gastro-intestinal liner, developed by Lexington, Mass.-based GI Dynamics, currently is being tested with 37 individuals as an alternative to gastric bypass surgery. Initial results from 19 patients who have completed the full 24-week trial show an average 1.5-point drop in a common measure of the amount of glycated hemoglobin, or HbA1c, in patients treated with the EndoBarrier device.
Test subjects each lost an average 33 pounds and also displayed significant reductions in plasma glucose levels, said Dr. Eduardo G. Moura of Hospital das Clinicas at the University of Sao Paulo, Brazil. Moura presented his findings, Ongoing Clinical Study of Endoscopic Duodenal-Dejunal Bypass Liner in Obese Type 2 Diabetics, at the GASTRO 2009 conference now running through Wednesday in London.
GI Dynamics officials described the preliminary results as “encouraging,” building on data from other recent patient testing of the EndoBarrier device. All of the 37 patients taking part in Dr. Moura’s single-arm, open-label study previously were approved for more invasive procedures such as gastric bypass surgery, which reduces the size of the stomach and allows food to bypass the upper portions of the small intestines.
In the 19 patients completing the 24-week study, HbA1c levels fell from an average of 7.8 percent to 6.3 percent, returning to what is typically considered an acceptable level for most patients with Type 2 diabetes. Fasting plasma glucose levels — a key test for diabetes — likewise fell from 141.1 milligrams per deciliter to an average of 124.8 milligrams, indicating “impaired” glucose tolerance but actually falling below the 125- milligram threshold when diabetes usually is diagnosed.
The data “show the potential of non-surgical therapeutics in controlling diabetic factors and facilitating weight loss” in patients suffering with both type 2 diabetes and from obesity, said Stuart Randle, chief executive at GI Dynamics. “We look forward to sharing additional results from this study upon completion of the trial.”
Overall, about 250 individuals have tested using the EndoBarrier, which prevents food from coming into contact with the intestinal wall and believed to alter the activation of hormonal signals originating in the intestine. Other recent tests of the device have shown similarly positive results, including study results released earlier this month that found extremely obese people with uncontrolled Type 2 diabetes were able to nearly normalize glycemic levels after one week compared with a control group.