New Approaches to Type 2 and New Devices for Obesity

Gretchen Becker Health Guide
  • We'd all like to see a cure for type 2 diabetes on the horizen, but so far, it's not in the works. All we can hope for at the moment is improved gizmos and gadgets that might make our lives a little easier but won't cure the underlying problem, or new approaches to treating patients that might improve our care.


    Some of the proposals for new approaches to both obesity and diabetes at the recent Cleveland Clinic Innovation Summit were as follows:


    Tailoring, or developing biomarkers that would show which subpopulations or individual patients would benefit from a specific treatment and which would not. As patients, we understand the concept of YMMV (your mileage may vary). Some physicians who follow evidence-based medicine that is based on average responses don't seem as willing to tailor the results to the individual and probably won't until there's some way of measuring individual risks.

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    Focusing on comorbidities of obesity rather than weight itself. If someone is overweight but otherwise active and healthy, the situation is different from that in a person who is overweight with bad knees and impending heart failure. In the latter case, the obesity should be viewed as a progressive disease, not a cosmetic problem, said Steve Nissen, chairman of cardiovascular disease at the Cleveland Clinic. "The FDA is missing the point when they focus on weight loss, not comorbidities."


    Using implanted devices that would transmit data not only to the patient, as with current continuous glucose monitors, but to health care providers, or, in the case of children with diabetes, to parents.


    Finding better outcome measures. One speaker said that at autopsy, they find that 40% of diagnoses were wrong.


    Five new devices to treat established obesity were described at the meeting. None are yet on the market. A sixth device, the EndoBarrier, was demonstrated by a vendor. It is available in Europe but not yet in the United States.


    BaroSense is working on a system to implant a silicone barrier at the end of the esophagus to induce a sense of fullness. You can see an animation of the procedure at the Physician section of the site. It is implanted through the mouth and is called TERIS (transoral endoscopic restrictive implant system). It is intended to be a long-term device used along with "lifestyle changes," but it can be removed if the patient no longer needs it, according to the company's CEO, Daniel Balbierz.


    IntraPace is working on technology similar to that used in cardiac pacemakers. The "abiliti" system uses a laparoscopically implanted stomach sensor to detect food or drink. The device then delivers electric impulses designed to make you feel full before the stomach is full. You can see an animation of the system on the Technology page of the site.


    The system also records the output of the food sensor and an activity sensor, and this information can be downloaded at the doctor's office, so you and your doctor can analyze eating and exercise patterns.


    I wonder if simply knowing that someone could detect how often you ate would make a lot of people eat less.


    No trials to measure the effectiveness of the system have been done with type 2 patients, according to Chuck Brynelsen, CEO of IntraPace, but he said they're anticipating 40% weight losses with the device.


    ReShape Medical  has a balloon system that is inserted through the mouth and is designed to make you feel full sooner. There have been balloon systems before, and none have become popular. Sometimes the balloon would rupture and cause a blockage in the intestine.


    What makes this device different is that it consists of two balloons connected by a flexible tube. If one leaks or deflates, the other will continue to function and will keep the other one from migrating and clogging the intestines. Also, because of the two balloons, it's longer and narrower than other balloon devices, so it's easier to insert and remove.

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    The balloons are filled with blue saline, so if they leak badly, you will have blue urine, which you'll probably notice.


    They are intended to be left in place for six months, during which time you are expected to change your lifestyle patterns. Then the balloons are removed. Bill Murray, CEO of ReShape, said he thinks lots of patients could maintain the six-month weight loss if they were enrolled in support groups. "This is a jump start," he said. "It helps them understand they need to eat less."


    Satiety has produced a device uses suction and staples to create a narrow "sleeve" at the top of the stomach designed to limit the amount of food you can eat at one time. Again, you can see an animation, by clicking on Toga Procedure.


    This device is reported to be furthest along in getting FDA approval. CEO Eric Reuter said they hope to get the device to the market sometime next year.


    ValenTx CEO James Wright spoke about their device, which is designed to mimic gastric bypass without surgery. The device is inserted via the mouth and excludes food from the stomach; the food emerges about 100 cm down the intestine (in the jejunum).


    Their Web site is under construction, but those with a technical interest can see a patent application. If you register, you can see the illustrations. But, like many patent applications, the text describes various alternatives that may be used, and it's not clear which ones would be in the final version that would be marketed.


    Wright said initial studies show results similar to those of gastric bypass. He said the device is designed for long-term use.


    Finally, the EndoBarrier, although not one of the devices picked by Cleveland Clinic staff, was demonstrated in the lobby. Well, they showed the device. They didn't offer to implant one.


    Like the ValenTx, the EndoBarrier is designed to mimic the popular Roux-en-Y bypass surgery by inserting a plastic sleeve through the mouth and into the intestine, so food bypasses the upper part of the small intestine, where various hormones are secreted. There are animations of the procedure on the Web site. It is not designed to be permanent.


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    Unlike the other devices, this one is already on the market in parts of Europe.


    All these treatment approaches and new devices are good. But let's face it. We'd rather have a cure.



Published On: December 07, 2010