U-M expert discusses a clinical trial involving a new non-invasive, endoscopic weight-loss procedure called the EndoBarrier®.
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.
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 that developed EndoBarrier®, a non-invasive EBMT for individuals with type 2 diabetes and obesity. And they are enrolling patients in a new clinical trial at the University of Michigan.
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 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.
Michigan Medicine is one of four participating sites in the pivotal study (STEP-1) evaluating this device. The study consists of randomized EndoBarrier® implant and control arms. Both arms receive identical lifestyle therapies that comply 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.
My colleague, Elif Oral, M.D., who is a professor in the Division of Metabolism, Endocrinology and Diabetes at Michigan Medicine, puts it best: Essentially, EndoBarrier® is an option for patients who have obesity and type 2 diabetes who are looking to start insulin therapy to improve their glucose control but do not want to gain weight.
It promotes hormonal modulation to help with weight loss and diabetes amelioration.
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.
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.
This work is very important to me because minimally-invasive procedures have the potential to truly impact the treatment of obesity and diabetes 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 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.
The current study is exciting because this particular device was developed primarily for the treatment of type 2 diabetes, although also leads to weight loss. Many experts now believe that the diabetes that arises in the setting of obesity should be handled differently from diabetes not associated with obesity. This is one STEP in the right direction for that!
We hope that the study will prove safe and effective, utilizing the new protocol that GI Dynamics has developed with their scientific advisors.
For further information and/or potential participation, please contact Rita Hench at (734) 232-2144 or Adam Neidert at (734) 615-0539.
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