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Clinical Trial for People With Type 2 Diabetes
January 25, 2013
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.
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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