The EndoBarrier procedure is similar to gastric bypass surgery, but its supporters say it’s less expensive, less intrusive, and can be removed after a year in place.
People in England fighting “diabesity” — late-onset diabetes associated with obesity — may soon have an alternative to gastric bypass surgery.
Advocates say the device called the EndoBarrier — a 60 centimetre long tube-like liner or “sleeve” inserted into the intestines to stop the absorption of food — can help overweight people with type 2 diabetes.
The sleeve can be implanted under anesthesia through the person’s mouth in less than an hour.
Dr. Robert Ryder, consultant diabetologist and chief investigator for the Association of British Clinical Diabetologists’ studies with the EndoBarrier, presented his findings at the annual meeting of the European Association for the Study of Diabetes (EASD) in mid-September in Portugal.
The research indicates that the new, nonsurgical, reversible weight loss device is safe and effective and could be introduced across Britain’s National Health Service (NHS).
The procedure’s intent is to kick-start lifestyle changes and to help people achieve better health.
Officials at GI Dynamics Inc. in Boston, which manufactures the EndoBarrier, said its device isn’t approved for sale in the United States and is limited by federal law to investigational use only in this country.
To explore whether this new therapeutic method could work on a large scale, Ryder and his colleagues at City Hospital in Birmingham created a small NHS EndoBarrier clinic.
They opened it in October 2014 to work with patients who were hardest to treat.
Sixty-five people were accepted for treatment and 50 now have the EndoBarrier implanted successfully.
“We translated our research program into an inaugural NHS service, which demonstrates EndoBarrier to be highly effective in patients with refractory [resistant to treatment] diabesity,” Ryder told Healthline. “There are high patient-satisfaction levels and an acceptable safety profile.”
“After we removed the EndoBarrier,” he added, “65 percent of the patients were able to sustain the benefits achieved in blood sugar and weight control, and in insulin-dose reduction. They also reported considerable improvements in well-being, energy, fitness, and exercise ability. Endoscopy units are ubiquitous, so our service could be readily disseminated, and the registry would be useful for ongoing monitoring nationwide and worldwide.”
In such a procedure, a small part of the stomach is used to create a new stomach pouch about the size of an egg.
This smaller stomach is connected directly to the middle portion of the small intestine, bypassing the rest of the stomach.
This reduces the amount of fat and calories the body absorbs from the foods consumed.
The EndoBarrier prevents the body from digesting food in that area, so absorption occurs farther down the intestine. This causes people to feel full after just a small meal.Advocates say the device called the EndoBarrier — a 60 centimetre long tube-like liner or “sleeve” inserted into the intestines to stop the absorption of food — can help overweight people with type 2 diabetes.
The sleeve can be implanted under anesthesia through the person’s mouth in less than an hour.
Dr. Robert Ryder, consultant diabetologist and chief investigator for the Association of British Clinical Diabetologists’ studies with the EndoBarrier, presented his findings at the annual meeting of the European Association for the Study of Diabetes (EASD) in mid-September in Portugal.
The research indicates that the new, nonsurgical, reversible weight loss device is safe and effective and could be introduced across Britain’s National Health Service (NHS).
The procedure’s intent is to kick-start lifestyle changes and to help people achieve better health.
How the device works
Officials at GI Dynamics Inc. in Boston, which manufactures the EndoBarrier, said its device isn’t approved for sale in the United States and is limited by federal law to investigational use only in this country.
They opened it in October 2014 to work with patients who were hardest to treat.
“We translated our research program into an inaugural NHS service, which demonstrates EndoBarrier to be highly effective in patients with refractory [resistant to treatment] diabesity,” Ryder told Healthline. “There are high patient-satisfaction levels and an acceptable safety profile.”
“After we removed the EndoBarrier,” he added, “65 percent of the patients were able to sustain the benefits achieved in blood sugar and weight control, and in insulin-dose reduction. They also reported considerable improvements in well-being, energy, fitness, and exercise ability. Endoscopy units are ubiquitous, so our service could be readily disseminated, and the registry would be useful for ongoing monitoring nationwide and worldwide.”
In such a procedure, a small part of the stomach is used to create a new stomach pouch about the size of an egg.
This smaller stomach is connected directly to the middle portion of the small intestine, bypassing the rest of the stomach.
This reduces the amount of fat and calories the body absorbs from the foods consumed.
The procedure is similar to a gastric bypass, Ryder said, but is far less invasive, less risky, and less expensive. The device can also be removed, usually after one year.
The first 31 patients — between 28 and 62 years of age — have had their EndoBarriers removed after up to one year.
While the device was implanted, Ryder said he and his physician colleagues regularly encouraged their patients to change their diets and lifestyles, and to exercise.
The researchers also established a secure online registry to monitor outcomes.
Some risks, some success
The EndoBarrier isn’t without risks.
“There is the possibility of serious adverse events, such as gastrointestinal hemorrhage and liver abscess — usually resolved by removal of the device,” Ryder said.
On average, Ryder and his colleagues said, their patients lost 33 pounds, had improved blood sugar control, lower blood pressure, and less liver fat.
Participants on insulin were able to reduce their dose from 100 units per day to 30, he added.
“Participants also reported considerable improvements in well-being, energy, and the ability to exercise,” Ryder said.
Around 94 percent said they would recommend the service to their friends and family.
A leading American diabetes researcher is encouraged by Ryder’s success with the EndoBarrier.
“Obesity is the main cause of type 2 diabetes, and obesity makes blood glucose levels harder to control in people with type 2 diabetes,” Dr. Thomas A. Buchanan, told Healthline. “If people with type 2 diabetes can lose weight, they usually have better blood sugar levels, which lowers their risk of long-term diabetic complications like vision loss, kidney damage, nerve damage, heart attack, and stroke.”
Buchanan, chief of the Division of Endocrinology and Diabetes at the University of Southern California Keck School of Medicine, is co-director of the USC Diabetes and Obesity Research Institute.
“Lifestyle changes can help reduce obesity, but the effects are generally mild and not sustainable over long periods of time,” he said. “Surgical approaches are much more effective, but they have significant complications.”
“This sleeve approach offers a less invasive way to help people lose weight and keep it off. This study shows that it works in even longstanding, hard-to-control cases of type 2 diabetes.”
Maintaining improved health
“For lifestyle changes alone, 95 percent of patients return to their pre-intervention weight by five years,” Buchanan said. “Old habits are tough to break over time. For this device, we need to see what the long-term weight loss pattern is. One year is pretty short. Lifestyle changes work well for that period of time, too.”
Early studies showed some incidence of the EndoBarrier sleeves slipping out of place, Buchanan noted.
“I am not sure if this version has that risk,” he said. “Also, longer studies are needed to see if the device creates any nutritional deficiencies. I doubt it, but it is possible.”
Many people living with diabetes remain overweight with poor diabetes control.
By the time someone first develops type 2 diabetes, they already have incurred 10 to 20 years of damage to the insulin-secreting cells in their body, Buchanan said.
Much of that damage is the result of obesity. And that damage continues to occur over time if people remain obese.
“Lifestyle approaches simply don’t create sustained weight loss,” Buchanan said. “Most medications we use lower blood glucose levels. But with one or two exceptions, they don’t stop the ongoing damage to insulin-secreting cells, so the blood sugars go back up again eventually.”
“Surgical approaches are used relatively late, usually for severe obesity,” he added. “The horse is out of the barn by then. We need approaches that can fix obesity for long periods of time. And we probably need to use them earlier and for lesser degrees of obesity than is the current practice. This [EndoBarrier] sleeve is a new approach that has great potential in that regard. We just need to see how it does over the long term.”
https://www.healthline.com/health-news/new-device-could-help-people-with-diabetes-lose-weight#5
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