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Clinical Trial for People With Type 2 Diabetes

By Diane Fennell
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If you have uncontrolled Type 2 diabetes and are obese, you may be interested in a clinical trial that is currently recruiting participants to test the EndoBarrier, a new device intended to improve diabetes control and promote weight loss.

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According to developer GI Dynamics, the EndoBarrier “is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine.” It is placed into the intestine via the mouth during a brief, reversible endoscopic procedure (a process that involves inserting a thin, flexible tube called an endoscope through the mouth and into the stomach). The device is designed to change the body’s response to food by altering the release of hormones, and it can stay in the intestines for up to a year.

This is the first US-based, multicenter clinical trial to investigate the potential benefits of the EndoBarrier in obese people with uncontrolled Type 2 diabetes. The trial is expected to enroll approximately 500 people meeting specific enrollment criteria in up to 25 sites in the United States. It is designed to evaluate improvements in diabetes control as measured by HbA1c (an indicator of blood glucose control over the previous 2–3 months), as well as reductions in weight and improvements in cardiovascular risk factors.

The EndoBarrier has been studied in 12 clinical trials outside the United States as well as one in the United States with over 500 participants. In previous trials, the device was shown to quickly reduce blood glucose levels and cause weight reductions of roughly 20% in 12 months. It is currently approved for use in 20 centers around the world.

“We’re excited to initiate this important trial in the US,” noted Lee M. Kaplan, MD, PhD, lead study investigator and director of the Obesity, Metabolism & Nutrition Institute at the Massachusetts General Hospital and Harvard Medical School. “Results from the pilot studies of EndoBarrier have been very promising, and we look forward to determining the efficacy and safety of this device in this large, controlled, pivotal trial.”

For more information about the EndoBarrier, and to see if you might qualify for the EndoBarrier Trial, visit www.endobarriertrial.com or call (888) 9STUDY9 [(888) 978-8399].

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  • Janice Cunningham

    I had gastric bypass in 2003 (10 years ago) but am still obese. Would I be a candidate for EndoBarrier having had this surgery?

  • jim snell

    I remembering seeing this in Journals and stories from England.

    Why our medical science in America has its brains and ideas locked on target over the just add more insulin/ actos/avendia at the problem rather than looking at glucose saturation from constant overload of glucose generation of the hunter gatherer gene digestion system optimzed to prevent starvation escapes me.

    There seems to be more and more data that says reef back on the glucose generation – roux Y, intestine liner, extreme 600 calorie diets all screaming out to cut off the excess glucose generation from 24/7 availability of incredible grains, refined foods and low exercise due to couch potato appliances, tools, computers, video games, wide screen tv.

    The present mentaility completely ignores the fact the glucose regulation in a hunter gatherer body is a storage based opertaion that as long as room in the glucose temporary storage sites of the skeletal muscle/fat system of the human body, blood system regulation continues properly. That involves proper carb input regulation as well as sufficient physical energy to exhaust the glucose trapped in muscles on regular basis and set up a balanced energy equation.

    Current thinking is trapped on the thought that this storage is infinite and goes on forever when in fact it is human, typical and is finite.

  • JohnC

    Jim.. you are no doubt a very smart man, but it sure was easy to get lost in your posting 🙂
    Maybe it would be easier to say our bodies (genetic) are still waiting for the next famine (which never comes) — put on lots of reserve weight to get us through.

    Simply I have found that if you never give your body a chance to produce very much insulin you will keep the weight down. Of course that means limiting certain foods with lots of carbs. All calories are not equal.

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