July 03, 2019 9:00 AM

Minimally-Invasive, Innovative Therapy Used for Treating Type 2 Diabetes and Obesity

U-M expert discusses an upcoming clinical trial involving a new non-invasive, endoscopic weight-loss procedure called the EndoBarrier®.

woman on scale

Endoscopic and metabolic therapies, or EBMTs, are innovative, non-invasive weight-loss procedures designed to significantly reduce a patient’s stomach volume or alter other parts of the digestive tract to treat obesity and other metabolic diseases.

Unlike traditional bariatric surgery, an endoscopic bariatric procedure is performed using a small, flexible scope inserted through the patient’s mouth.

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With many patients failing to meet surgical requirements for traditional bariatric surgery or afraid of undergoing operations, EBMTs are quickly starting to gain popularity.

GI Dynamics® Inc. is a medical device company currently developing EndoBarrier®, a non-invasive EBMT for individuals with type 2 diabetes and obesity. And they will be enrolling patients in a new clinical trial at the University of Michigan later this year.

U-M’s principal investigator, Allison R. Schulman, M.D., M.P.H., is an assistant professor of gastroenterology and internal medicine, as well as the director of bariatric endoscopy at Michigan Medicine.

Michigan Health Lab spoke to Schulman about the upcoming study, called STEP-1. 

Tell us more about the STEP-1 study: What does it entail?

EndoBarrier® is a duodenal device that is placed and removed endoscopically. This device is being evaluated for patients with type 2 diabetes and obesity who have failed pharmacological therapy, and who do not qualify for or do not wish to undergo bariatric surgery.  

Doctor image
"Minimally invasive procedures have the potential to truly impact the treatment of obesity by expanding the population of treatable patients."
Allison R. Schulman, M.D., M.P.H.

Michigan Medicine will be one of four participating sites in the upcoming pivotal study (STEP-1) evaluating this device. The study will consist of randomized EndoBarrier® implant and control arms. Both arms will receive identical lifestyle therapy that complies with the American Diabetes Association guidelines. 

The primary goal of the STEP-1 study is to reduce, on average, blood sugar levels (HbA1c) in patients after 12 months of treatment.

What type of work do you do as a gastroenterologist at Michigan Medicine?

I am an interventional endoscopist at Michigan Medicine, with a focus in bariatric endoscopy. 

My area of clinical and research interest is the endoscopic management of obesity and obesity-related comorbidities, in addition to innovation and device development in the field of endoscopy. 

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This work is very important to me because minimally invasive procedures have the potential to truly impact the treatment of obesity by expanding the population of treatable patients.

Can you tell us the benefits of non-invasive endoscopic procedures for weight loss (and otherwise)?

Given the growing obesity epidemic and the increasing costs of health care in the United States, the demand for accessible, less-invasive bariatric therapies has amplified. EBMTs have evolved into same-day, outpatient endoscopic procedures with significant weight loss results, as well as improvements in obesity-related health problems and a low rate of adverse effects. 

These procedures often fill the gap between lifestyle interventions and surgical interventions, and may be an excellent, less-invasive option for people who have tried diet and exercise without success. Many of these patients are not candidates for surgical procedures or are unwilling to undergo a surgical procedure.

In certain situations, these interventions may also offer bridge therapy for patients who require weight loss prior to being considered for other types of surgery, including knee or hip replacements, or organ transplants. This is an emerging and exciting field for the treatment of obesity and its related complications and is rapidly gaining momentum. 

Because of these benefits, my team and I are eager to start enrolling patients for the STEP-1 study. And we hope it will prove safe and effective with the new protocol that GI Dynamics has developed with the support of their scientific advisors.

The STEP-1 pivotal study will begin enrolling patients with type 2 diabetes and obesity during the second half of 2019.