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 centimeter 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.
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.”
The EndoBarrier lines the first 60 centimeters of the small intestine.
"This mimics the bypass bit of a roux-en-y gastric bypass," Ryder said.
"Roux-en-y" is named for Dr. Roux, who invented the surgical procedure. The Y denotes the configuration of the stomach and bowel segments involved.
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.
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.
These people had lived with obesity and type 2 diabetes for an average of 13 years and more than half (17 people) were taking insulin.
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.
These patients reported that the device helped them to lose weight and improve their health.
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.”
One person’s story
One of Ryder’s patients, Harnaik Pharhani, told Healthline about his successful experience with the EndoBarrier.
Married and the father of two children, Pharhani, age 53, has type 2 diabetes and once weighed 294 pounds.
“My blood sugar and cholesterol levels were very high,” Pharhani said. “I used to have a lot of protein in my urine. I would feel really low because of my health problems, and this in turn would make me irritable. When I tried to exercise, I just couldn’t do it. I would feel too tired, and I was breathless going upstairs, or going out for walks.”
In March 2015, he had an EndoBarrier implanted at City Hospital in Birmingham, part of the Sandwell and West Birmingham Hospitals NHS Trust.
What happens after an EndoBarrier is implanted?
“Changes started happening slowly,” Pharhani said. “I didn’t consciously change my diet much, but I stopped craving certain things like fried foods, chips, and kebabs. I didn’t feel the urge to eat those kinds of things anymore. The amount of food I ate also started decreasing.”
Over the course of one year, Pharhani experienced significant health changes. He lost 49 pounds.
His cholesterol dropped from 232 to 154. His blood pressure went from 146/125 mmHg to 124/85 mmHg, and his blood sugar level went from between 18-24 down to 6-8.
There was also less protein in his urine.
Beyond the dramatic improvement in his numbers, Pharhani experienced other successes.
“It has been life changing,” he said. “I feel a lot more positive within myself. I feel I can do a lot more, too. I now play a lot of sports, including badminton against 18-year-olds, who don’t like it when they lose to me. There’s a significant difference in my stamina.”
Pharhani says his improved health has brought him other simple pleasures.
“One of my ambitions was to buy clothes at a regular shop, instead of going to specialist shops that stock larger sizes,” he said.
Now he can. He likes the way he looks, too.
“People complain about having a double chin,” Pharhani said. “I had a triple chin, and people thought I looked like I was in my 60s. Now the weight has fallen off, and they say I look 10 years younger than my real age. And I don't have a triple or double chin.”
Pharhani’s success has led to life changes and good habits.
“I try and keep active, and go to the gym as much as I can,” he said. “My wife, Surinder, goes to the gym with me as well, and is very supportive. I continue to keep away from fried foods, and I don’t crave the unhealthy food I once did. I don’t tend to overindulge on food either, and I have drastically reduced the amount of sugar in my diet.”
Pharhani said he would recommend that the United Kingdom roll out the EndoBarrier treatment across the National Health Service. Some of Pharhani’s relatives, impressed with his success, said they’d like to undergo the same treatment.
Dr. Elizabeth Robertson, director of research for Diabetes UK, is cautiously optimistic about the future of the EndoBarrier.
“Type 2 diabetes can lead to devastating complications such as blindness, amputations, and stroke,” she told the Diabetes Times. “So, it’s essential people with the condition receive the very best care, and are given the support they need to manage their condition well.”
“The results of this trial are promising, but long-term, large-scale studies are still needed to understand the true impact of using EndoBarrier to manage type 2 diabetes,” she said.