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George Armstrong, a type 2 diabetic who lives in Sydney, Australia, was feeling well enough – but he noticed he was gaining weight, and his insulin-dependency made it difficult to lose weight.
Armstrong’s hemoglobin A1C (HbA1c) levels –an indicator of how well your diabetes is controlled – was increasing, and his doctors were worried.
Married with three grandchildren, Armstrong had no desire to cut back on his active lifestyle, so he did some research on the EndoBarrier device – a thin, flexible tube-shaped liner that fits inside the intestine, creating a barrier between food and the intestinal wall.
“I’m the youngest of three brothers; all three of us have diabetes . . .and we’ve all had open heart surgery,” Armstrong told FoxNews.com. “One did not survive, so I had more than a normal reason to pursue diabetic relief.”
EndoBarrier has been approved for use in the United Kingdom, Netherlands, Australia, Germany, Austria and Chile. Now, a Food and Drug Administration-approved trial will study the effects of the device throughout several cities in the U.S.
Type 2 diabetes affects more than 23 million people in the U.S. and approximately 320 million worldwide. It occurs when the pancreas can’t effectively produce insulin and is usually associated with obesity.
The EndoBarrier has shown “rapid reductions in blood sugar levels and weight loss of approximately 20 percent,” according to GI Dynamics, which manufactures the product. GI Dynamics has partnered with Medtronic and GlaxoSmithKline to study the device’s benefits in a randomized, double-blind sham-controlled study.
The device is fitted through an endoscopy – so the patient would only be lightly sedated during the procedure. There is only minimal discomfort after the procedure, according to Dr. Lee M. Kaplan, lead investigator and director of the Obesity, Metabolism & Nutrition Institute at the Massachusetts General Hospital and Harvard Medical Center.
Armstrong said he had a little stomach pain after the July 2012 procedure, but it diminished rather quickly – and he has not used insulin once since then.
His glucose levels went back to normal, and he lost 44 pounds.
Armstrong said the device has given him a reduced appetite, so he eats less frequently (although he is still able to enjoy the occasional ‘luxury,’ or dessert).
Kaplan said for many people with chronic illnesses such as diabetes, lifestyle changes are not enough to manage the disease – and additional interventions are ultimately needed.
“Approximately 500 participants are slated to participate in the trial, two-thirds of whom will get the device implanted and one-third of whom will get what is called a ‘sham’ procedure (meaning they’ll have an endoscopy, but no device will be implanted),” Kaplan said.
Kaplan said neither the patients nor the investigators will know if a device was implanted until the end of one year. At that point, if the study’s results were effective, the patients who had a sham procedure can opt to receive a device.
There is still room left in the study for this interested in participating. In order to become eligble, you must be between the ages of 21 and 65, be obese with a body mass index between 30 and 50, and have uncontrollable type 2 diabetes, despite treatment with metformin and/or a sulfonylurea drug. Participants should have a HbA1c level between 8 and 10 percent.
“The device appears to change the patient’s physiology so that diabetes is brought under better control,” Kaplan said. “As with other therapies for diabetes, obesity and other metabolic disorders, the benefit of the EndoBarrier is likely to be increased if patients also choose to improve their lifestyle with a healthy diet, regular physical activity, adequate sleep and stress management.”
Armstrong is so happy with the results of the EndoBarrier, he likened it to replacing the SIM card in a cellphone.
“The whole package has completely changed,” Armstrong said. “It’s amazing.”
Visit endobarriertrial.com for more information.