Billings Clinic study aims to help diabetics lose weight
4 hours ago • By LAURA BAILEY For The Gazette
Emerging research is finding that the first two feet of the intestine are no small thing when it comes to weight management.
The area, known as the duodenum, is directly linked to appetite. It signals fullness to the brain and plays a key role in blood sugar regulation.
A research trial for a new medical device at Billings Clinic aims to help diabetes patients — and eventually many others — lose weight by focusing on that area.
Three Billings patients are participating in a study of the EndoBarrier, a thin plastic sleeve that is attached to the uppermost portion of the intestine and blocks the absorption of nutrients in the duodenum. The device is inserted endoscopically through the mouth while the patient is under minimal anesthesia.
The trial is being coordinated locally by Dr. Christopher Sorli, an endocrinologist at Billings Clinic. The study began in January and Billings Clinic was the first site to enroll a patient. Two more patients were added this summer. There are 22 sites across the country participating in the study, and researchers are hoping to enroll 300 patients. For now, the study is being done on overweight diabetic patients, but with more research, and another trial, the EndoBarrier could become available for overweight patients.
“We have a huge epidemic of obesity,” Sorli said. “It’s the epidemic of our generation. Because of the complexity of the problem, diet and exercise don’t always work.”
The research behind the development of the EndoBarrier began about 40 years ago with the advent of gastric bypass surgery, a procedure that divides the stomach into two sections and re-routes the intestine to the stomach. Over the decades, researchers began to understand the importance of the duodenum. Shrinking the stomach, they discovered, didn’t always alleviate hunger, mainly because the fullness signal comes from the duodenum. It’s also an area especially influenced by hormones, which influence blood sugar.
“The more we learn about it, the more complex it gets,” Sorli said.
Unlike gastric bypass, the EndoBarrier provides a solution to weight management that does not permanently alter the patient’s anatomy.
The EndoBarrier is made of thin polymer, similar in strength and weight to a produce bag from the grocery store. It’s anchored with a circular series of hooks and allows essential secretions from the gall bladder and pancreas to flow between the barrier and the intestine wall, while contents from the stomach flow through the tube. It takes about 20 to 25 minutes to put it in and to retrieve it, Sorli said.
The nationwide trial is expected to take two years. The EndoBarrier is inserted in the patient's intestines for one year. The patient is monitored in the second year for any changes in weight and blood sugar.
As with any medical trial conducted to study the effectiveness of a medical device, there are two groups — an active treatment group, which in this case received the EndoBarrier, and a control group, which did not. All the patients went through an endoscopic procedure and were told they received the device. During the course of the study, their weight-loss efforts and blood sugars will be closely monitored for changes.
Once the EndoBarrier is approved, those who did not receive the device during the trial will have the option to receive one, Sorli said.
The EndoBarrier is already available in 13 countries, with the first overseas human trials being done in 2007-'08. Typically, patients who take a diet-and-exercise approach to weight loss experience tiredness and hunger between meals. The studies showed that patients with the EndoBarrier saw no drop in energy, and reported feeling fuller after having eaten less, Sorli said.
Over the course of the year that the device was implanted, EndoBarrier patients easily dropped 20 percent of their body weight or more and were better able to control blood sugar. Long-term studies have shown that people who used the EndoBarrier for a year “reset” their weight and blood sugars to healthier levels and haven’t needed any additional interventions to keep the weight off, Sorli said.
More patients are needed for the EndoBarrier trial. To qualify to be included in the study, patients must be a Type 2 diabetic, overweight, and taking Metformin or/and another sulfonylurea drug. Their AIC blood tests must show a stable, average blood sugar of 8.0 percent or more. The ideal patient for the study must also be between the ages of 18 and 65.
For more information, contact Billings Clinic’s endocrine department at 238-2500.
