A new endoscopic procedure called re-cellularization via electroporation therapy (ReCET) showed promise in a small, early-stage study, allowing Type 2 diabetes patients to come off insulin for a year.

Details on the procedure

In the study, which has not been peer-reviewed, 14 patients underwent an endoscopic procedure delivering alternating electrical pulses to their duodenum in the small intestine. After the procedure, which lasted an hour, the patients were discharged and put on a calorie-controlled liquid diet for two weeks before being given semaglutide.

Of the 14 patients in the study, 12 were able to maintain good glycemic control without needing insulin for a year.

It's unknown what specific change occurs to the duodenum to make the body resistant to its own insulin, but the researchers hypothesized the cause could be chronic exposure to a high-sugar, high-caloric diet. They believe ReCET rejuvenates the tissue in the small intestine, allowing the body to respond to its own insulin again.

Discussion

Jacques Bergman, a professor of gastrointestinal endoscopy at Amsterdam University Medical Center (AUMC) and principal investigator on the study, said ReCET "might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis."

Bergman added that ReCET is "'disease-modifying' in that it reverses the body's resistance to its own insulin."

"The potential for controlling diabetes with a single endoscopic treatment is spectacular," said Celine Busch, lead researcher on the study and a PhD candidate in gastroenterology at AUMC. "One of the biggest advantages of this treatment is that a single outpatient endoscopic procedure provides [blood sugar control], a potential improvement over drug treatment, which depends on patients taking their medication day in, day out."

Ali Aminian, a professor of surgery and director of the  Bariatric and Metabolic Institute at the Cleveland Clinic, said the treatment's effect is plausible, and the preliminary findings "on a very small number of patients with a very short follow-up time are interesting."

However, he said the study's use of semaglutide was a notable shortcoming. "When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy," he said, especially "when we add a strong diabetes medication like semaglutide."

Bergman noted that semaglutide was used to "boost the insulin-resistant effect of the endoscopic treatment" and that the researchers have planned a double-blind randomized trial that will "show how much semaglutide actually contributed to the effect." He added that the goal of ReCET is to eliminate the need for any medications.

Busch also noted that when people add semaglutide to their insulin treatment, only around 20% can stop taking insulin, compared to the 86% who were able to in the study.

Aminian said he's "looking forward to better quality data … from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes."

But, he noted that, "in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies." (Hart, Forbes, 4/28; Klein, The American Journal of Managed Care, 4/28; Tucker, Medscape, 4/28)