HonorHealth Research Institute trial explores a way for type 2 diabetes patients to eliminate insulin shots

The ‘Revitalize’ clinical trial aims to resurface the lining of the small intestine, resetting the body’s natural way of controlling blood sugar

SCOTTSDALE, Ariz. — June 11, 2024 — 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 (GI) tract. 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.

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 from type 2 diabetes, currently more than 30 million Americans.

Minimizing the need for medications

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

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

Site: HonorHealth’s Shea campus

The Revitalize procedure will be conducted at HonorHealth’s Scottsdale Shea Medical Center by Amar Thosani, M.D., a leading specialist in interventional endoscopy and a board-certified gastroenterologist. The first procedure as part of this clinical trial was performed June 6.

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, explained Dr. Thosani.

“We’re hoping to burn that mucosa tissue — denude it — and then have it grow back into normal tissue,” he said.

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 a limited number of patients, 15, will be enrolled through the Institute for this study, which will last 1 to 2 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.

According to the CDC: more than one in 10 Americans are diagnosed with type 2 diabetes, and another four in 10 are at risk. Diabetes disproportionately affects Hispanics, Native Americans and African Americans. About 1.4 million new cases are diagnosed annually in the U.S.

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

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