In October of that year, Oggelsby had a thin, flexible sleeve implanted in his upper intestine via an endoscopy in hopes of taking back control of his health. “I felt as though I didn’t have anything to lose by giving it a go,” Oggelsby says. He says the device, called the EndoBarrier, helped him lose 68 pounds and lower his A1C from 7.3 to 6.6. According to the American Diabetes Association, A1C is a two- to three-month average of blood sugar levels. Oggelsby’s A1C reduction suggested he was getting closer to 6.4, the upper threshold of prediabetes, but was still in the diabetes range. Despite Oggelsby’s sustained health improvements as of early 2019, experts say the EndoBarrier needs improvements and is far from ready for prime time. In November 2017, its manufacturer, GI Dynamics, removed the EndoBarrier from the market in Europe because of safety concerns. Now experts speculate that the device likely won’t return to market unless the company makes dramatic changes. RELATED: 7 Signs Your Blood Sugar Is Out of Control
Why the EndoBarrier Was Taken Off the Market Across the Globe
The EndoBarrier never made it to the U.S. market, but it was available in Europe, the Middle East, and South America from 2010 until 2017, says Scott Schorer, the president and chief executive officer of GI Dynamics in Boston. Schorer says the EndoBarrier was available in Australia from 2011 until 2016. In 2015, GI Dynamics discontinued its U.S. clinical trial, the ENDO Trial, after doctors found that about 3.5 percent of participants with the device in the U.S. had a hepatic abscess, while the rate worldwide was 0.73 percent, according to GI Dynamics. Hepatic abscess is a bacterial infection of the liver that is deadly if left untreated, according to Johns Hopkins Medicine. “Until those [safety concerns] are corrected, it’s hard to know how useful it really will be,” says Eric J. DeMaria, MD, the president of the American Society for Metabolic and Bariatric Surgery (ASMBS), a professor, and the division chief of general/bariatric surgery of the department of surgery at East Carolina University in Greenville, North Carolina. RELATED: The Best Diabetes-Friendly Foods to Fight Belly Fat
How Does the EndoBarrier Device Work?
Similar to gastric bypass surgery, the EndoBarrier separates food from the digestive juices in the intestine. The procedure is reversible, and the EndoBarrier was designed to stay in place for 12 months. “It’s intended to mimic that part of the gastric bypass, which we know is an important part of glucose improvement after the surgery,” says Stacy Brethauer, MD, a past president of the American Society for Metabolic and Bariatric Surgery (ASMBS) and a surgeon at the Cleveland Clinic in Ohio. “We don’t know exactly what that mechanism is, but we know that the food interaction in that part of the bowel can contribute to diabetes, and when you stop having that interaction, the diabetes gets better,” he says. Gastric bypass surgery reduces absorption of calories and carbohydrates, resulting in weight loss and better blood sugar control, according to an article published in October 2012 in Gastroenterology. Although the EndoBarrier doesn’t lower the amount of calories the body absorbs, it appears to help regulate hormones. “It creates a metabolic signal that changes the levels of your key hormones that regulate satiety, hunger, insulin sensitivity, and insulin production,” says Schorer. Dr. Brethauer says more research is needed on the mechanism behind the EndoBarrier. “This device potentially does affect the gut hormones, but we don’t know exactly which ones and in which way yet,” he says. RELATED: 5 Fermented Foods Good for People Managing Diabetes In general, research on the EndoBarrier is limited, but early studies suggest it may offer health benefits for people with type 2 diabetes. According to a meta-analysis published in May 2017 in the journal Gastrointestinal Endoscopy, participants with obesity and type 2 diabetes who had the EndoBarrier removed after eight months reduced their A1C (a two- to three-month average of blood sugar levels) by 1.3 percent and lowered their weight by 14.2 percent. What’s more, five studies in that analysis suggested a significant decrease in glucose-dependent insulinotropic peptide (GIP), a hormone that stimulates insulin secretion, seven months after removal of the device. (There is no long-term research on whether the device can help sustain those results after its removal.) In people with type 2 diabetes, hyperglycemia (high blood sugar) causes the pancreas to overproduce insulin to try to regulate blood sugar levels. In the short-term study, it appeared that the EndoBarrier lowered that insulin production in conjunction with lowering blood sugar and weight. Because much of the focus for EndoBarrier has been on diabetes, it’s unclear whether the device leads to weight loss alone in people without the disease. “There’s a lot of unknowns right now with EndoBarrier because it’s still being studied,” says Dr. DeMaria. “We don’t really have the type of studies we need to understand what it does.” RELATED: 8 Genius Weight-Loss Steps for People With Type 2 Diabetes
How the EndoBarrier Device May Compare With Gastric Bypass Surgery
Schorer says the EndoBarrier is a safer alternative to gastric bypass surgery, which comes with the risk of internal bleeding and infection. But critics point out there is no long-term research on the safety of the EndoBarrier. According to a December 2017 article in the journal Obesity Surgery, insertion of the EndoBarrier resulted in 4 percent, or 5 of 114 patients, developing a gastrointestinal hemorrhage, and 2 percent, or 2 of 114 patients, developing a liver abscess. “Both GI hemorrhage (4 percent) and severe infection with liver abscess (2 percent) are higher than one would expect with an endoscopic procedure and more in the range of what might be expected with major surgical procedures,” DeMaria says. “In particular, liver abscess is an unusual infectious complication and is rarely seen after most bariatric operations, including gastric bypass surgery. These major complications are clearly higher than we would expect following a procedure with only temporary benefit that is simply not nearly as effective as bariatric surgery.” According to a March 2016 study published in the journal Diabetes, Obesity and Metabolism, side effects of the EndoBarrier include abdominal pain, nausea, and vomiting. After the 20-minute implantation, patients may also experience an uncomfortable, prickling sensation as the EndoBarrier settles into the intestine, and if they don’t comply with a postsurgical liquid then soft food diet, food could shift the device and cause bleeding, Schorer says. As mentioned, there is no long-term research analyzing potential A1C and weight fluctuations in people who have had the EndoBarrier device removed. RELATED: 5 Ways to Help Lower Your A1C Bariatric surgery, on the other hand, does have good long-term research showing that gastric bypass, a form of this procedure, can lead to sustained weight loss and type 2 diabetes prevention and remission in some people. In a September 2017 study published in the New England Journal of Medicine, researchers followed 1,156 participants with severe obesity for 12 years. They found that compared with people who did not have the procedure, those who underwent gastric bypass were more likely to avoid or put type 2 diabetes in remission, and lose and keep the weight off compared with those who did not have the surgery. Nevertheless, this surgery is imperfect: Researchers in the September 2017 study reported seven suicide deaths, which occurred in people who had the surgery, among the participants. In addition to the aforementioned health risks of bleeding and infection, new research shows suicide may be a concern among people who have had bariatric surgery. For example, a randomized, prospective study of Swedish participants who did and did not undergo bariatric surgery drew a link between the procedure and a higher rate of suicide and nonfatal self-harm. The researchers, whose study was published online in January 2018 in The Lancet, Diabetes & Endocrinology, called for more postsurgical mental-health care among bariatric surgery patients. For what it’s worth, in the short term, the EndoBarrier does not appear to help participants sustain their health results. According to an April 2015 study in the journal Gastroenterology, the EndoBarrier appears to help temporarily put diabetes in remission. But once a surgeon removes the device from a patient, which usually occurs 12 months after implantation, glucose levels may rise again. “It doesn’t happen instantly, but over the course of a year or so, their blood glucose starts rising again,” Brethauer says. The patient may have to repeat the treatment, seek out another intervention, or take medication when the effects of the device wear off, as fewer than 1 percent of people can maintain weight loss through diet alone, says Brethauer. Although the device can help people eat less, “it’s going to be dependent on the patient on how long they can sustain that behavior,” he says. RELATED: For Diabetes Control, Gastric Bypass Trumps Lifestyle Changes, Study Suggests
Why Combining Medication and the EndoBarrier May Improve Type 2 Diabetes Management
Complementing the use of the EndoBarrier with medication may be one key to sustained health benefits. A study published in July 2018 in the journal Diabetes found the EndoBarrier device combined with Victoza (liraglutide), a drug that doctors may prescribe for weight loss maintenance after bariatric surgery, is more effective at controlling diabetes and weight loss than the device or the drug alone. “Anything you can do to sustain the effect is going to be helpful,” Brethauer says. RELATED: For Weight Loss, Semaglutide May Be More Effective Than Liraglutide, Study Suggests Although doctors usually prescribe diet and lifestyle changes in conjunction with EndoBarrier implantation, experts say for people who are obese, those measures may not be enough without further treatment. In fact, a February 2015 article in Lancet Diabetes & Endocrinology shows that although people can be successful in the first few months of a weight loss program, between 80 and 95 percent will put the weight back on. Schorer says that’s where the EndoBarrier may help. “The first thing you need is a metabolic change, meaning the device has to create a metabolic set point that’s different from your current set point. You can then choose from a range of outcomes for your lifestyle,” he says. Even temporary improvements in weight and A1C may help decrease the chances of diabetes-related health complications, such as heart disease, diabetic neuropathy (nerve damage), and retinopathy (eye problems), Brethauer says. “Even if it goes back up later, you’ll still have that legacy effect of that time that you were under control,” Brethauer says. RELATED: How Diabetes and Heart Disease Are Connected
What May Be Ahead for the EndoBarrier Device in the U.S. and Worldwide
In 2019, GI Dynamics is working to re-attain its certification to design, create, and sell the EndoBarrier in the European Economic Area (EEA) once again. The EEA consists of countries in the European Union, along with Iceland, Liechtenstein, and Norway. The company has no plans to reenter the Australian market at this time, a company spokesperson from GI Dynamics says. In August 2018, the Food and Drug Administration approved GI Dynamics for a new U.S. trial of the EndoBarrier, which Schorer says will likely be underway during summer 2019. GI Dynamics has also selected a new notified body to continue their work to regain their CE mark. “We’re close to resolving everything, and we’re hopefully soon focused on a bright future for this technology.” Although safety issues around the EndoBarrier have yet to be resolved, experts say that the device or a similar treatment will be available in the U.S. in the future. “I think it has potential, but I think we have to wait for the study results to know,” DeMaria says. RELATED: 12 Great Apps for People Managing Type 2 Diabetes When the device was on the market, getting the EndoBarrier implanted cost between $7,000 and $10,000. Insurance companies did not cover the device when it was on the market, Schorer says. Oggelsby had the EndoBarrier removed in November 2017, shortly before the device was pulled from the market that same month. Oggelsby says the key to maintaining his weight loss has been eating less and exercising more — something he attributes the device to helping him kick off. Although he still takes metformin, he stopped taking insulin in July 2018. “I feel as though it’s given me a lot more life,” he says.
