More than one-third of adults in the U.S. are obese and more than 23 million have type 2 diabetes. Now, there’s a treatment that could fight both of these common health problems.
A couple of years ago, Gale Johnson got a diagnosis she feared would come—type 2 diabetes.
“I have a list of medications that I take,” Gale told Ivanhoe.
Patients like Gale might not need meds at all! Doctors at Washington University are studying the EndoBarrier for type2 diabetes.
“It’s essentially doing the same kind of thing that you would get from surgery,” Shelby Sullivan, MD, Gastroenterologist, Washington University in St. Louis, told Ivanhoe.
Doctors insert the plastic-like device through a tube, passed through the mouth and stomach into the first part of the small intestines. When food passes, the EndoBarrier forms a barrier between it and digestive enzymes in the intestine. Researchers believe the device may also alter hormone signals in the digestive tract.
“It’s affecting metabolism in a way that it’s improving diabetes,” Dr. Sullivan said.
The device is already approved in Europe, Australia, Chile, and Israel, but is still in clinical trials in the U.S. In previous studies, patients experienced a weight loss of about 20 percent and improved their hemoglobin A1c levels by two points.
“That helps a diabetic because it’s getting their blood sugar under control. So, it actually may help them get off medication,” Dr. Sullivan said.
Currently, the device is being placed in patients for just one year and is then taken out. However, Dr. Sullivan says the patients previously studied still saw long-term effects even after it was removed. Risks are extremely rare, but include poking a hole in the small intestine and blockages in the intestines.
BACKGROUND: Type 2 diabetes is a condition which affects more than 26 million people in the U.S. It is the most common type, affecting 90 to 95 percent of those with diabetes, a condition where your body doesn’t use blood glucose in the proper way. Type 2 diabetes means your body either doesn’t create enough insulin or your cells ignore the insulin that is produced, instead leaving it in the blood. In either case, your cells may be starved of the energy that the insulin provides, and long term the buildup of glucose can affect your sight, kidneys, feet, or heart. (Source: http://www.diabetes.org/diabetes-basics/type-2/facts-about-type-2.html)
SYMPTOMS: Those with type 2 diabetes sometimes won’t show any symptoms, but these are some of the most common:
* Increased thirst or hunger (especially after eating)
* Increased urination
* Blurred vision
* Numbness or a tingling sensation in your hands or feet
* Dry mouth
* Nausea or vomiting (Source: http://www.webmd.com/diabetes/guide/type-2-diabetes?page=2)
NEW TECHNOLOGY: A new treatment called EndoBarrier is already available in parts of Europe and South America is being investigated in the U.S. EndoBarrier is a tube-shaped liner that goes into your intestine, and blocks food from being digested by the upper part of the intestine. This affects hormone levels associated with hunger as well as insulin sensitivity, although doctors are unsure as to why it has this effect. Patients who underwent a preliminary study saw an average 20 percent weight loss and improved blood glucose levels. The procedure to put the EndoBarrier in takes about 20 minutes and is an outpatient procedure. (Source: http://www.medicalnewstoday.com/articles/245022.php, and Shelby Sullivan, MD)
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Shelby Sullivan, MD, Gastroenterologist, Washington University in St. Louis, talks about a new treatment for diabetics.
What is EndoBarrier?
Dr. Sullivan: EndoBarrier is a gastric intestinal liner that’s placed in the first part of the small intestines called duodenum and it acts like the part of the gastric bypass procedure when we re-arrange the small intestine. So it’s essentially doing the same kind of thing that you would get from the portion of the surgery that creates what’s called the biliopancreatic limb.
What does it do?
Dr. Sullivan: It’s affecting metabolism in a way that’s improving diabetes and it will also cause some weight loss. Now exactly how it’s doing that we don’t completely understand. But we know that gastric bypass is a metabolic surgery that does affect both feelings of hunger and also the hormones that are released from the gut. The way this procedure differs from gastric bypass is that this is just an endoscopic procedure which is a same day procedure: we make you sleepy, and we use an endoscope to introduce this sleeve into your stomach. And then you deploy it into the small bowel. You recover from this and go home the same day. We don’t do any external cutting, everything is done internally.
What is it made out of?
Dr. Sullivan: It’s made out of a material that prevents absorption of food contents from actually interacting with the lining of the small intestine until it passes out of that liner, which is about 60 cm long. So food doesn’t get absorbed until it hits that end of the 60 cm. Food does still actually get absorbed it’s just being sensed in a different part of the intestine. We’re just beginning to understand the different changes that occur with hormones when you have nutrients sensed in a farther out part of the small intestine when you don’t have it in the first part of small intestine.
And that affects diabetes?
Dr. Sullivan: In previous studies this has actually improved diabetes. One of the markers that we look at is hemoglobin A1C and in those previous studies the EndoBarrier had a big impact on hemoglobin A1C, even better than some medications.
So how does that help a diabetic?
Dr. Sullivan: It helps by getting blood sugar under control. Again, we don’t completely understand how this happens.
This helps just type II diabetics? And only ones that are on oral medication and not shots?
Dr. Sullivan: For the study we are looking for people who are only on oral medications and are not on insulin. Although in the future this may be used for people who are also on insulin.
So have you seen it completely reverse the symptoms of diabetes and get people off of drugs altogether?
Dr. Sullivan: Well, we are just beginning the study at our site, but we expect that some participants will get off of at least some of their medications during the trial.
And you don’t know why it’s so important not to let the food get in the beginning?
Dr. Sullivan: No, nobody really knows the answer to that and there’s a lot of research being done in that right now.
How does it affect the metabolism?
Dr. Sullivan: We don’t completely understand how it affects the metabolism and there are probably a couple of different components. One is that this device does result in some weight loss, so that will also improve their diabetes. But it also has an effect that’s independent of weight loss and we don’t completely understand that. But we know from bariatric surgery that when you bypass the first part of the small intestine that you get a metabolic effect on diabetes.
So if this works could this be the replacement for four oral medications altogether?
Dr. Sullivan: For some patients it could be the replacement of oral medication. It’s probably not going to replace all medication but it could replace some medications and it could also be used as an adjunctive therapy to people who are already on medications and maybe not be getting maximum benefit.
How long does it last?
Dr. Sullivan: This device is currently being looked at for being placed for one year. In the future it may be able to be placed and then taken out and then replaced again. But for right now where really looking at one year and then what happens after the device is removed.
Are there any risks?
Dr. Sullivan: There are always risks to any device or any procedure that we do. With this particular device there’s a risk of poking a hole in the small intestine where there shouldn’t be one. The other risk is that there could be a blockage. Even though it’s anchored in the first part of the small intestine, there’s always a risk that it would become un-anchored and travel down the small intestine. If we can’t reach it endoscopically, surgery would be required to remove it. But again that’s a very, very small risk.
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