ENDO Trial explores investigational treatment option for type 2 diabetes

Gastrointestinal Associates, along with Endocrinology Consultants of East Tennessee, is proud to be participating in a national clinical trial to explore the effectiveness and safety of an investigational treatment for type 2 diabetes that centers on the use of a thin, flexible tubular sleeve (liner) called the EndoBarrier. The trial, the ENDO Trial, will provide valuable information on the use of the EndoBarrier in people who have type 2 diabetes and are obese.

The EndoBarrier is designed to change the way the body responds to food by altering the release of hormones that may help reduce appetite and improve the body’s ability to control blood sugar.

The EndoBarrier is placed in the body endoscopically, which means it’s inserted using a thin, flexible tube called an endoscope that is passed through the mouth and into the stomach at the beginning of the small intestine. The procedure is reversible and does not alter the body’s natural anatomy. EndoBarrier may stay in place for up to one year to help manage blood sugar and body weight. After 12 months of treatment, the device is removed endoscopically.

The EndoBarrier device creates a physical barrier between the food you eat and a portion of the intestinal wall. It allows food to bypass the main absorption area of the small intestine, creating an endoscopic by-pass.

Research into this promising treatment option clearly is warranted.

Diabetes and obesity are growing at epidemic proportions across the United States. Here in Tennessee, our percentages are even worse than the national average. According to “F as in Fat,” a collaborative project of the Trust for America’s Health and the Robert Wood Johnson Foundation, Tennessee is currently the 10th most obese state in the nation. The organization also reports that about 11.9% of Tennesseans have been diagnosed with diabetes, compared to a 6 % national average.

Type 2 diabetes accounts for at least 90 percent of all cases of diabetes and affects more than 23 million people in the United States. With type 2 diabetes, the body either doesn’t make enough insulin – a hormone that regulates the movement of glucose (sugar) into your cells – or doesn’t use it properly. The result is a buildup of glucose in the bloodstream that, over time, can damage your eyes, kidneys, nerves or heart.

The EndoBarrier has been approved and is available in Chile, Israel, Australia and several countries in Europe. Findings presented at the American Diabetes Association’s 74th Scientific Sessions in San Francisco demonstrate that the device shows promise – for example, a 29% drop in average daily glucose within days of implantation despite a 50% reduction in insulin dose.

We are excited to be participating in this trial and hope that many area residents will benefit from this treatment option.

Because the ENDO Trial is a clinical study, candidates must be carefully screened to ensure they meet all requirements for participation. The study will include adults between the ages of 21 and 65 who have uncontrolled type 2 diabetes and are obese and are currently using up to two oral diabetes medications including: metformin, a sulfonylurea, a DPP4 inhibitor or a thiazoldinedione (e.g. Actos or Avandia) but unable to achieve glycemic control. Individuals being treated with other medications, including insulin, are not eligible to participate in the study.

To see if you meet the criteria for participation in the ENDO Trial, please take a few minutes to complete the pre-screening questionnaire. For more information about the ENDO Trial or any health concerns, you may call our offices at (865) 622-3442.