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<span>Never before performed in Indiana, this innovative procedure may transform the lives of patients with diabetes.</span>

Indiana University selected as premier US site to study novel endoscopic procedure

Foreground: A doctor in scrubs holds an endoscope with a light. Background: A clinician preps a patient for an endoscopic procedure.

Three faculty members from the Department of Medicine will participate in a cross-collaborative study investigating a novel endoscopic procedure that could give people with diabetes the ability to come off insulin therapy.

This procedure is called “duodenal mucosal resurfacing,” or Revita DMR. It is an endoscopic procedure that relies on a technique called hydrothermal ablation to burn off the superficial lining of the duodenum, which is a portion of the proximal small intestine. The procedure triggers a new, healthy duodenal lining to regrow, and resets the balance of gut hormones that regulate the metabolic process.

Raj Vuppalanchi, MD, hepatologist and principal investigator of the study, says there is a serious need for this type of intervention. Dr. Raj Vuppalanchi

“High rates of obesity and diabetes are leading to more patients with serious liver problems, such as non-alcoholic steatohepatitis (NASH), cirrhosis, and liver cancer,” said Vuppalanchi, who is Professor of Medicine and Director of Clinical Hepatology.

According to Vuppalanchi, people with diabetes and NASH are at increased risk of progression to cirrhosis. The treatments currently available for these conditions are limited; they involve either complex daily medication regimens or invasive surgical procedures, such as bariatric surgery, for which not all patients are candidates.

“We are looking for a compromise: a less invasive procedure, and the ability to come off insulin without daily intake of medication,” Vuppalanchi said. “That’s where this procedure fits in.”

A collaborative approach to a complex problem

Dr. Zeb SaeedWhen food passes from the stomach to the small intestine, several hormones in the gut are triggered to stimulate many important metabolic functions. But in some people, this complex signaling process goes awry, according to Assistant Professor of Clinical Endocrinology Zeb Saeed, MD.

“The gut is a crucial organ in making hormones, including those that control glucose homeostasis,” she said. “But in people with type 2 diabetes, the gut microbiome and these important hormones are altered, leading to insulin resistance. It’s a vicious cycle.”

Duodenal mucosal resurfacing gets right to “the heart of this problem,” she said.

By burning off the lining of the duodenum, the procedure effectively “tricks” the body into thinking that no food has entered the small intestine—and therefore prevents the cascade of hormonal and microbial interactions that cause insulin resistance.

The same effect is seen in bariatric surgery, said Saeed.

“We know that people who undergo bariatric surgery often see an immediate and dramatic improvement in their blood glucose levels, long before they lose any weight,” she said, which suggests that it is the surgery’s alteration of the gut microbiome, and not weight loss, that improves insulin sensitivity.

Saeed, who describes understanding the pathophysiology of diabetes as a “calling,” said she is excited to participate in the study, which complements her concurrent research projects.

“This is why I went into medicine—to go deep into the basic sciences and solve problems at their core,” she said.

Dr. Mark GromskiMark Gromski, MD, the advanced interventional endoscopist who will perform the procedure, said the study also lies at the intersection of his interests.
“My practice is based on complex interventional endoscopic procedures, and I also have clinical and research interests in endoscopic management of obesity and metabolic disease,” said Gromski, who is an Assistant Professor of Medicine.
He is currently undergoing the additional training necessary to perform the novel endoscopic procedure, which has never been performed in Indiana.

"The technical components of the procedure are not dramatically more complex, or even much different, than what I do day-to-day in my endoscopy practice,” he said. “The building blocks of the procedure are not novel.”

This particular application of the procedure is novel, however, he said.

“It’s exciting to be part of a new approach to a problem that plagues us in Indiana,” Gromski said. “It’s also fun to work together as a team, and to join with my colleagues from across our respective bubbles.”

IU’s resources: high levels of skill, robust research activity, and the “Hoosier mentality”

Prior studies of duodenal mucosal resurfacing, conducted outside the United States, have shown promising results.

IU is the first of several study sites to be activated in the US. It was selected for its national leadership in advanced interventional endoscopy, its record of robust clinical trial enrollment, and its key personnel Vuppalanchi, Saeed, and Gromski.

“Not every institution has this combination of a hepatologist who is well-versed in the treatment of NASH; an endocrinologist looking for alternative treatment strategies for diabetes; and an advanced endoscopist with the high level of skill necessary to do this procedure,” Vuppalanchi said.

Additionally, Vuppalanchi expressed gratitude and admiration for everyone involved in making the study happen, including the study coordinators, nurses, and, of course, the study participants.

The study, which will run for a duration of one year, is currently recruiting participants. Vuppalanchi expects ten or more be enrolled. It will be randomized and double-blinded; only Gromski will learn at the last minute whether to conduct the real procedure or the ‘sham’ version, said Vuppalanchi, and he will be blinded to the outcomes.

All enrollees will have the opportunity to undergo the real procedure eventually, he added.

“A recurring theme I hear from patients in clinical trials is that they’re happy to participate for the greater good. They say, ‘Hey, it’s okay if I don’t benefit—someone else might,’” he said. “I am always so impressed by the mentality of the Hoosiers who are motivated to help others.”

Vuppalanchi, Saeed, and Gromski seem to share this mentality, too.

“This isn’t going to be a cure-all. It’s not going to cure these problems for everyone,” Gromski said. “But adding more tools to the toolbox is really important."

The views expressed in this content represent the perspective and opinions of the author and may or may not represent the position of Indiana University School of Medicine.
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Hannah Calkins

Hannah Calkins is the communications manager for the Department of Medicine.