HonorHealth conducts study to treat diabetes patients without insulin shots

A new clinical trial study at HonorHealth Research Institute could potentially wean patients with type 2 diabetes off the need to inject insulin by returning a key segment of the intestine to its natural state.

The Revitalize study will test the effectiveness of a tool called Revita, which is designed to remodel the lining of the duodenum, the segment of the small intestine that connects the stomach to the rest of the gastrointestinal tract, a press release explained.

The goal is to return the 10- to 15-inch-long duodenum to its natural function of helping to maintain the body’s blood-sugar balance, thereby decreasing or eliminating the need for daily injections of insulin.

“We’re trying to change how we treat diabetes,” Dr. James Swain, medical director of the Research Institute’s GI/Bariatrics Research Division and the principal investigator supervising the Revitalize study, stated in the release.

The procedure — in which the damaged lining, or mucosa, of the duodenum is ablated, or burned away, by super-heated water — has the potential to significantly improve the health of those who suffer with type 2 diabetes, currently more than 30 million Americans, the release stated.

“The more insulin you take, the more insulin you need. So, we’re trying to break that cycle,” Swain stated. “Revitalize is a new way to tackle diabetes without medications. We’re trying to alter the physiology to improve diabetic control.”

The Revitalize procedure will be conducted at HonorHealth’s Scottsdale Shea Medical Center by Dr. Amar Thosani, a specialist in interventional endoscopy and gastroenterologist. The first procedure as part of this clinical trial was performed on June 6, according to the release.

The lining of the duodenum can become damaged or altered over time due to multiple genetic and environmental factors, including a chronic diet of high-fat, high-sugar foods, Dr. Thosani explained.

“We’re hoping to burn that mucosa tissue — denude it — and then have it grow back into normal tissue,” Thosani stated in the release.

To be eligible for the Revitalize clinical trial, patients must be: diagnosed with type 2 diabetes, aged 21-70, and on a stable daily dose of insulin.

Only 15 patients will be enrolled through the Institute for this study, which will last one to two years, depending on whether the patient initially receives the actual procedure, or is randomly assigned first to a comparative placebo process before undergoing the actual procedure, the release detailed.

The Revitalize clinical trial is sponsored by Fractyl Health, based in Lexington, Mass., which is the manufacturer of the Revita tool.

For information about enrolling in the Revitalize study, call 480-323-1292.