One-hour endoscopic surgery could make type 2 diabetes patients insulin-free

Jack Bergman, MD, PhD
Credit: University of Amsterdam Medical Center

New data from early-stage studies published in Digestive Disease Week (DDW) 2023 It suggests that a single 1-hour endoscopy may eliminate the need for insulin use in patients. type 2 diabetes When combined with drug therapy.

The results of this study showed that a therapeutic approach consisting of recellularization by electroporation and the use of a GLP-1 receptor agonist was associated with significantly improved glycemic control, with 86% of participants achieving indicate that you have stopped using insulin.¹

“Drug therapy is ‘controlling the disease,’ but as long as the patient continues to take the drug, it will only lower hyperglycemia,” said lead investigator and director of gastrointestinal endoscopy at the University of Amsterdam Medical Center. Professor Jacques Bergman, MD, PhD, said. He is a member of Endogenex’s Advisory Board.² “This one procedure is ‘disease-modifying’ in that it reverses the body’s resistance to its own insulin, the underlying cause of type 2 diabetes.”

The EMINENT study is the first human study fully funded by Endogenex, the Minnesota-based company that owns the technology used in this procedure, to show that the new endoscopic procedure can be used without negative consequences. It was initiated with the goal of finding out if it could help reduce the need for insulin. Affects glycemic control in patients with type 2 diabetes. Called Re-Cellularization via Electroporation Therapy (ReCET), it uses electroporation to ablate the lining of the small intestine mucosa and induce cell apoptosis without damaging tissue architecture.¹

The primary feasibility endpoints of this study were procedure time, technical success rate, and proportion of patients tolerating GLP-1 receptor agonists. Of note, procedure time was defined as the time from catheter in to catheter out. The primary efficacy endpoint of interest was the number of subjects with HbA1c ≤7.5% who did not report insulin use at 6 months; included the incidence of significant adverse events and hypoglycemic events.¹

To participate in the single-center trial, participants had to be between 28 and 75 years of age, with a BMI of 24 to 40 kg/m2 and an HbA1c of 8.0% or less. According to the study protocol, the patient was discharged on the same day as the procedure, and he was placed on a calorie-controlled liquid diet for two weeks. After 2 weeks, the patient began titrating semaglutide to 1 mg weekly.¹

The median age of the 14 patient cohort was 62 (IQR, 54-67) years and 57% were male. Further analysis of baseline characteristics revealed a median BMI of 28.8 kg/m2 (IQR, 25.1–31.2), a median HbA1c of 7.2% (IQR, 7.0–7.4), and a median time of 72% (IQR, 7.0–7.4) in the study cohort. 46-85), the median daily insulin units used was 26 (IQR, 22-33).¹

The analysis showed a technical success rate of 100% for the ReCET procedure, a median axial treatment length of 12 (IQR, 10-14) centimeters, and a median procedure time of 58 (IQR, 49-79). ) minutes. The results also showed that no device-related serious adverse events were observed in the study. One patient reported a hypoglycemic event, but the researchers noted that the event did not require third party assistance.¹

The primary efficacy analysis showed that 12 of 14 subjects (86%) were insulin free. Further analysis showed that median HbA1c decreased from 7.2% at baseline to 6.6% (IQR, 5.8-6.9) at 6 months, with median time in range from 72% to 91% at 6 months. (IQR, 62-96) was shown to be increased. The researchers also highlighted a more than 50% reduction in the amount of liver fat observed among the participants.^1,3

“The potential to control diabetes with a single endoscopic procedure is fantastic,” said lead investigator Celine Busch, a PhD candidate in gastroenterology at the University of Amsterdam Medical Center.² “One of the biggest advantages of this treatment is that it provides glycemic control in a single outpatient endoscopic procedure. There is a possibility.”

References:

1. Busch CBE, Meiring S, Van Baar CG, Nieuwdorp M, Bergman J. Recellularization by electroporation therapy (ReCET) in combination with GLP1ra to replace insulin therapy in patients with type 2 diabetes: 6-month results of the EMINENT study. Gastroenterology Week 2023.
2. A one-hour endoscopic procedure may eliminate the need for insulin in type 2 diabetes. Eurekalert! https://www.eurekalert.org/news-releases/987253. Published 28 April 2023. Accessed May 4, 2023.
3. Ashmore M. A new endoscopic treatment improves glycemic control and eliminates the need for insulin in people with type 2 diabetes. DDW News. 2023 5 Published on the 3rd of the month. Accessed May 4, 2023.