In a first-in-the-nation procedure, AdventHealth tests promising new diabetes therapy

ORLANDO, Fla., May 23, 2019 — Doctors at AdventHealth performed the first U.S. procedure in a pilot study that researchers hope will lead to a groundbreaking new treatment for patients with type 2 diabetes.

The cutting-edge research from Fractyl Laboratories can be thought of in a similar way to our understanding of probiotics and their role of stimulating the immune system — ultimately leading to a healthier gut.  The research suggests a diet high in fats and refined sugars can damage the lining of the gut and lower the body’s insulin sensitivity. 

 

To reverse this damage, there is now a body of evidence gathered by Fractyl suggesting that by removing the unhealthy layer of overgrowth that has developed in the duodenum, the uppermost part of the small intestine, we may be able to press a “reset button,” rejuvenate the lining, and ultimately restore insulin sensitivity, allowing the body to properly regulate blood sugar without the need for additional medicines.

The procedure at AdventHealth marked the first use of the Revita duodenal mucosal resurfacing (DMR) system from Fractyl Laboratories in the U.S. 

In an outpatient procedure, a physician endoscopically inserts a balloon catheter into the duodenum.  The balloon is then inflated and heated. The heat destroys the excessive layer of the lining, to rejuvenate it and restore health.  The balloon catheter is removed after the procedure is completed.

“Type 2 diabetes is a chronic disease that requires constant daily monitoring and medications, in addition to healthy diet and exercise,” said Dr. Steven Smith, chief scientific officer of the AdventHealth Research Institute. “However, some patients, even with the best care and lifestyle modifications, are unable to control their blood sugar. That’s why Revita DMR is so exciting — it has the potential to deliver a ‘metabolic reset’ to help people with type 2 diabetes regain control.”

According to recent figures from the Florida Diabetes Advisory Council, more than 2 million Floridians are believed to have type 2 diabetes, and nearly 6 million have prediabetes. With obesity on the rise, those numbers are also likely to increase in coming years.

And despite the availability of medications to treat type 2 diabetes, most people in the U.S. still do not have adequately controlled blood sugar. This can lead to serious complications such as vision loss, heart disease and even amputations.

 “Given the prevalence of type 2 diabetes among Floridians, we need new treatment options beyond prescribing more drugs,” said Dr. Robert Hawes, medical director of the AdventHealth Institute for Minimally Invasive Therapy. “As a same-day, outpatient procedure, I believe Revita DMR could prove to be an effective alternative treatment that targets the underlying cause of type 2 diabetes and helps the body to better regulate blood sugar.”

Five clinical trial sites nationwide, including AdventHealth Orlando, will enroll a total of 18 participants, between 28-65 years of age, with poorly controlled type 2 diabetes. To be eligible, individuals must have been diagnosed with diabetes for at least three years and must have a hemoglobin A1c (HbA1C) level of 7.5-9.5% (59-80 mmol/mol). 

The other trial sites are located in New Hampshire, Pennsylvania, and Texas.  A full list of trial sites as well as inclusion and exclusion criteria is available at clinicaltrials.gov.

For patients in Florida with interest in participating in this trial, contact the recruitment team at TRI@flhosp.org or 407-303-7100.