GI Dynamics, a medical device company pioneering the development of new approaches to treat obesity and type 2 diabetes, announced today a paper appearing in the advance online publication of the journal Obesity, which demonstrates that implantation of an innovative endoluminal sleeve mimics key, beneficial effects of Roux-en-Y gastric bypass (RYGB) surgery, inducing substantial weight loss and improved metabolic function in rats with diet-induced obesity. The dramatic effects of the removable device on blood glucose levels in this animal model suggest an important role for the duodenum (the first part of the small intestine) and jejunum (the central part of the small intestine) in the regulation of this metabolic function. GI Dynamics is developing an endoluminal sleeve, known as the EndoBarrier Gastrointestinal Liner, and is currently in late-stage clinical trials.

The study authors were recognized by the Obesity Society with The Obesity Awards for Outstanding Journal Research which recognizes exemplary research in basic, clinical, or population manuscripts published in the journal Obesity. This award was presented during a plenary session at the Obesity Society’s 2008 Annual Meeting on October 3-7 in Phoenix, AZ.

“We believe the weight loss and normalization of blood glucose levels observed in this study reflect the physiological effects of preventing contact between ingested food and the duodenum, thereby mimicking the effects of gastric bypass surgery. These animal data further support the potential role of endoscopic duodenal exclusion as a new treatment option for patients suffering from obesity and other metabolic conditions and may offer a valuable alternative to more invasive surgical approaches,” said Lee M. Kaplan, M.D., Ph.D., associate professor of medicine at Harvard Medical School, director of the Weight Center at Massachusetts General Hospital, and a co-author of the study.

To evaluate the effect of the EndoBarrier on body weight, the obese and diabetic rats were randomized into two groups; the first group received the device in the duodenum and the second group underwent a sham operation (control group). After seven weeks, the device treated rats weighed an average of 20% (p<0.001) less than those in the sham treatment group, and the difference in the two groups continued through the end of the 16-week follow up period demonstrating that treatment with the EndoBarrier resulted in sustained weight loss over time.

Caloric intake and percentage of calories absorbed by the gastro-intestinal tracts of both groups of rats were also evaluated. Treatment with the EndoBarrier resulted in a 28% (p<0.05) reduction in daily caloric intake. There was no difference in calories absorbed between the two groups, indicating that malabsorption is not a significant contributor to the weight loss. The study also found that the device prevented acute weight gain in lean, obesity-prone rats.

In addition, this study showed that treatment with the EndoBarrier substantially decreased fasting blood glucose (p<0.001) and insulin levels (p<0.02) compared to the sham treatment group, and improved oral glucose tolerance, as evidenced by a 40% decrease in the area under the curve analysis of glucose excursion. Improved peripheral insulin sensitivity was confirmed by calculation of the homeostasis model assessment of insulin resistance (HOMA-IR).

“The sustained weight loss and reduction in blood glucose levels seen in the rats treated with the EndoBarrier underscores what we’ve seen to date in our human clinical trials,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We recently announced new data from a clinical trial indicating that the EndoBarrier is a safe, noninvasive device with excellent short-term weight loss results in severely obese patients and the patients in this trial also experienced reductions in blood glucose levels. We look forward to conducting additional trials to further evaluate the device and are pleased to share these findings.”