According to the National Diabetes Information Clearinghouse, 8.3% of the US population or 25.8 million people are affected by diabetes, including an estimated 7 million with undiagnosed cases. The Centers for Disease Control and Prevention (CDC) has also noted that 35.7% of all adults and 16.9% of children (ages 2-9) are considered obese. Overall obesity rates are projected to exceed 40% by the year 2030 and over 60% in 13 other states.
Obesity is known to increase the risk of diabetes, heart disease and certain cancers, while also contributing to a decrease in life expectancy. The financial impact of treating these obesity related healthcare expenses cost billions of dollars each year. According to a Harvard study, the United States spent $190 billion in 2005 alone on both direct costs (inpatient and outpatient expenses) and indirect costs (value of lost work, insurance and wages) associated with obesity. Researchers have cautioned that by 2030, if the obesity trend continues unchecked, obesity-related healthcare costs alone could rise by $48 to $66 billion a year in the U.S.
With these startling statistics in mind, the healthcare industry continues to look for new and effective ways to manage and control obesity. In recent years, gastric bypass surgery was seen as a way to help patients lose weight when diets and exercise failed. While the procedure is generally considered safe and effective, it has its disadvantages. The reduction in the size of the stomach is essentially permanent and the removal of part of the small intestine limits the amount of nutrients patients can absorb to support bodily functions. Additional complications include adverse changes to digestive tract, problems digesting certain foods, and diarrhea.
Another option is the lap band surgery, which works by banding the stomach into an upper and lower section but this procedure also has several drawbacks. A lower weight loss is expected (40% with lap band versus 60% with gastric bypass) and there are also issues with passing or processing certain foods that are unable to fit through the smaller stomach opening (corn, rhubarb, asparagus, red meats, and breads). The potential need to loosen the banding after surgery due to nausea and issues with the band slipping or becoming compromised because of scarring are noted disadvantages as well.
As an alternative to gastric bypass and lap banding, GI Dynamics, headquartered in Lexington, Massachusetts, has begun clinical trials in the United States for EndoBarrier Therapy. Unlike other weight-loss surgeries the, EndoBarrier Therapy is designed to specifically treat both obesity and type 2 diabetes. While lap band and gastric bypass surgeries tend to help patients suffering from type 2 diabetes indirectly via weight loss, EndoBarrier Therapy does so directly, helping patients achieve glycemic control by reducing their HbA1c levels.
The EndoBarrier Therapy is a non-surgical treatment, administered through the patient’s mouth where a tube-shaped flexible liner is inserted through the opening of the stomach into the intestine, creating a barrier between the food and the wall of a portion of the intestine. The premise behind EndoBarrier Therapy is that this “barrier” between ingested food and the wall of the intestine causes the body to produce hormones that result in appetite reduction and improved control of sugar levels. Diet modifications are required for a period of time after the procedure to allow the patient’s body to adjust to the EndoBarrier. After that, diet changes include the elimination of certain foods and portion control. Patients are able to resume normal activities within a day after the procedure. The EndoBarrier can stay in place up to 12 months and is easily removed by the patient’s EndoBarrier physician in a 15 minute procedure.
The EndoBarrier Therapy is currently approved in the United Kingdom, Netherlands, Germany, Austria, Chile and Australia. While not currently approved in the United States, GI Dynamics announced on January 15th that The Billings Clinic in Billings Montana would be the first of several US locations for EndoBarrier clinical trial known as the ENDO Trial.
Estimated to complete data collection in June of 2015, the EndoBarrier therapy offers a unique and new approach to help those patients suffering from both type 2 diabetes and obesity.