There are more than 23 million people in the United States, including 1.6 million in New York State, who have type 2 diabetes, which occurs when the body is resistant to the action of insulin, a hormone produced by the pancreas to lower the blood sugar. Type 2 diabetes, which is often associated with obesity, can result in kidney failure, limb amputations, blindness, heart disease, and stroke when blood sugar levels are uncontrolled.
“Many of these individuals who are living with type 2 diabetes and obesity are trying tirelessly to manage their diabetes and blood sugar, but without success,” says Aida Saliby, MD, of the Department of Endocrinology at Beth Israel Medical Center. “They do not respond fully to diet and lifestyle modifications, or they become resistant to the effects of oral medications, requiring additional treatments to manage their disease. Given the severe and growing diabetes epidemic, there is a substantial need to develop new, more effective therapies,” she says.
Under the leadership of Dr. Saliby and David Carr-Locke, MD, Chief of the Division of Digestive Diseases, Beth Israel researchers are collaborating with the Gerald J. Friedman Diabetes Institute to enroll patients in a clinical trial to evaluate the EndoBarrier®, a new approach to type 2 diabetes treatment. The EndoBarrier is a thin, flexible tube-shaped liner designed to change the way the body responds to food by forming a physical barrier between food and a portion of the wall of the intestine, and altering the release of hormones. This may act to help reduce appetite and improve the body’s ability to control blood sugar, researchers believe.
“The device, which requires no incision, is guided through the mouth and into the stomach, where it is placed at the beginning of the small intestine,” explains Dr. Carr-Locke, who performs the procedure. “It is designed to stay in place for one year, and during that time we will measure blood sugar levels and weight before it is removed. Evidence to date suggests that there is continued control of blood sugar even after the device has been removed.”
The ENDO Trial will evaluate the efficacy and safety of EndoBarrier in individuals who have uncontrolled type 2 diabetes and are obese. Specifically, researchers will evaluate improvement in HbA1c, a measure of blood sugar; weight loss; and improvements in select cardiovascular risk factors, including cholesterol and blood pressure. Beth Israel is one of up to 25 clinical trial sites in the United States selected to participate in the study.
To learn more about the ENDO Trial, go to www.endobarriertrial.com or call 888-978-8399.