AURORA | Researchers say a new clinical trial at the Anschutz Health and Wellness Center could ultimately lead to a safe and affordable alternative to gastric bypass surgery.
The Health and Wellness Center is one of 25 sites nationwide taking part in the ENDO trial, a randomized clinical trial
designed to test a new approach to treating type 2 diabetes. The trial will focus on EndoBarrier, a medical device inserted through the mouth that forms an artificial barrier between a part of the intestine wall and food. Researchers involved in the trial say the thin, flexible device could mimic the effects of gastric bypass surgery. The EndoBarrier device is designed to affect the way the body responds to food, specifically in relation to the release of hormones and the regulation of blood sugar.
“This is the pivotal trial in the U.S.,” said Holly Wyatt, the medical director at the Health and Wellness Center and a lead researcher in the ENDO trial. “If this were to pan out … it would offer a great option for a lot of the obese patients out there who are struggling with keeping their diabetes in control.”
Depending on the results of the tests in Aurora and at the other trial sites across the country, the EndoBarrier could eventually become an alternative to bariatric surgery. That means patients dealing with diabetes or obesity who don’t make for good surgery candidates could have another option. Currently, the U.S. National Institutes of Health recommends gastric bypass surgery for those with diabetes and a Body Mass Index of at least 40.
“The EndoBarrier is a tube-shaped liner that forms that physical barrier between the food that you’re eating and the initial part of your intestine,” Wyatt said. “There seems to be some part of bypassing that part of the gut, at least in the surgical models, that seems to be really good in controlling diabetes.”
Wyatt said the randomized, blinded trial will last more than a year, and will compare effects of the EndoBarrier device and a “sham” device in participants. Those test subjects who receive the fake device will still have the option to test the EndoBarrier device at the end of the trial, Wyatt said.
“It’s kind of a win-win for people,” Wyatt said. “Right now we have four MDs that are involved. I have a staff of four or five regional assistants or coordinators. We have two medical teams to make sure everything goes smoothly.”
The national trial is the latest high-profile research to come out of the Health and Wellness Center, which opened only last year. Since opening its doors last spring, the center’s team of dieticians, physicians and wellness experts have already found a place in the national spotlight. Earlier this year, for example, the Health and Wellness Center announced a partnership with McDonald’s to promote healthy menu items to school kids. James Hill, the center’s executive director, said taking part in the ENDO trial aligns with the center’s ambitious mission.
“I think the real significance is that we want to be on the cutting edge, and this is totally cutting-edge technology,” Hill said. “We want to have the major trials in these areas. Anything to do with weight management, we want them to think of us.”
Specifically, Hill said the trial addresses a surgery that is becoming more and more common for millions of Americans, a procedure closely tied to the country’s obesity epidemic. According to 2011 statistics from the American Diabetes Association, 25.8 million children and adults in the United States, or 8.3 percent of the population—have some form of diabetes.
“We’ve got two-thirds of the adult population who are overweight or obese. Interestingly, the people who would ordinarily get bariatric surgery has risen from about 1 percent of the population 30 years ago to 10 percent,” Hill said. “Surgery is very expensive. Any time you do surgery, you’re permanently altering human physiology,” he added, saying the ENDO trial could offer an alternative for millions. “It would be a huge, huge breakthrough.”
Health and Wellness Center researchers are looking for 20 adults between the ages of 21 and 65 to take part in the trial. Nationwide, the trial will involve about 500 patients. Test subjects must have type 2 diabetes and must have a body mass index between 30 and 50 and a hemoglobin A1C count between 8 and 10. For more information, call 1-888-978-8399.
Reach reporter Adam Goldstein at [email protected] or 720-449-9707