Obese patients with uncontrolled Type 2 diabetes who were treated with an investigational endoscopic duodenal-jejunal bypass liner achieved near normalization of glycemic control in one week, as compared with a sham group.
Implantation of the liner was also associated with reductions in fasting blood glucose levels and weight loss.
The EndoBarrier (GI Dynamics) is a non-surgical therapeutic device that is implanted in the gastrointestinal tract through an endoscopic outpatient procedure. It creates a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system.
The single-blind study included 18 patients with Type 2 diabetes who had a baseline HbA1c of 9.1% and BMI of 38.9. Researchers randomly assigned patients to receive the liner (n=12) or a sham endoscopy (n=6). Diets were adjusted in the first two weeks to obtain similar weight loss. This was a 24-week study, extended up to 52 weeks.
Twelve weeks after the device was implanted, HbA1c levels improved by 1.3% among patients assigned to the liner vs. 0.7% among patients assigned to the sham device (P<.05). At 24 weeks, values continued to improve in the liner arm (2.4%) compared with the sham arm (0.8%; P<.05).
Twenty-four weeks after the device was implanted, HbA1c levels improved 2.4% among patients assigned to the liner vs. 0.8% among patients assigned to the sham device.
Patients treated with the liner achieved a 55-point reduction in fasting blood glucose levels compared with a 42-point increase in the sham arm (P≤.05). Liner-treated patients also achieved a 20% decrease in the area under the glucose curve during a meal tolerance test at week one but increased 17% in the sham arm (P=.016).
Mean body weight loss was similar between treatment arms through the first 12 weeks after implantation, with a slight trend toward more weight loss in the liner arm through 24 weeks.
According to the researchers, device migrations required removal of the device before reaching 52 weeks.
The most commonly reported adverse events were mild or moderate and included upper abdominal pain (30.8%), vomiting (10.8%), nausea (7.7%) and symptoms of hypoglycemia (7.7%).
“In clinical studies conducted to date with the EndoBarrier, patients have experienced immediate resolution of Type 2 diabetes while the EndoBarrier is implanted, and continued resolution of their diabetes after the device is removed, as well as the important benefit of weight loss,” Keith Gersin, MD, chief of bariatric surgery at Carolinas Medical Center, said in a press release. “These results are similar to those seen with gastric bypass surgery.”