04 May DDW23: Endoscopic ReCET Procedure Plus Semaglutide Eliminates Need for Insulin in Type 2 Diabetes

MedicalResearch.com Interview with:
Celine B. E. Busch, Research Associate
Gastroenterology and Hepatology Standard PhD Candidate
Dr. Jacques Bergman
Professor, Gastroenterology and Hepatology
Amsterdam UMC

MedicalResearch.com: What is the background for this study? Would you describe the ReCET procedure?

Response: Currently more than 400 million people worldwide have type 2 diabetes (T2D) and these numbers are rapidly increasing. At the moment there is no treatment option available that effectively treats the root cause of T2D, i.e. insulin resistance, the increasing loss of response to our body’s own insulin. T2D is generally treated with drug therapy, yet drug therapy can be expensive, requires the patient to take their drugs every day, and at best “controls” the disease without actually resolving it. Despite the availability of many T2D drugs, less than 50% of all T2D have adequately controlled blood glucose levels.

The duodenum (the first part of the small bowel, immediately distal to the stomach) has proven to play a crucial role in glucose homeostasis in T2D. We know from bariatric surgery, that bypassing the duodenum by an Roux-en-Y Gastric Bypass has an immediate and profound effect on T2D by improving the sensitivity to the body’s own insulin resistance. However, performing invasive bariatric surgery for many T2D is not feasible. But we can reach the duodenum easily via upper GI endoscopy.

ReCET is a single endoscopic procedure, performed under deep sedation. The ReCET catheter is advanced next to the scope, and once it is placed in the duodenum the flex circuit is unfolded until it touches the full circumference of the duodenum. The flex circuit contains the electrodes that create a pulsed electric field which “electroporates” the cells. Electroporation irreversibly makes small, that cause the cell to die of natural cell death, or apoptosis. This process can be precisely titrated for its depth of damage and does not generate heat thus avoiding damage to deeper wall layers, a major hurdle for standard endoscopic ablation techniques. The ReCET procedure lasts about 60 minutes to treat a 10-15 cm segment of the duodenum. The procedure does not cause significant side-effects and patients are discharged the same day.

MedicalResearch.com: What are the main findings?

Response:  ReCET is a feasible and safe endoscopic treatment. ReCET in combination with a GLP-1 receptor agonist (semaglutide) was able to eliminate insulin therapy in 86% of the patients. Despite the fact that patients were off insulin therapy they had better regulation of their blood glucose and a better metabolic health at both 6 and 12 months follow-up.

MedicalResearch.com: Is this a procedure that could be amenable to widespread adoption?

Response:  Yes it is. Although currently only performed as part of clinical studies by experienced interventional endoscopists, we expect the ReCET procedure to be further simplified, thus shortening the duration of the procedure and making it within the reach of general endoscopists.

MedicalResearch.com: What recommendations do you have for future research as a results of this study?

Response: We are planning a double-blind sham-controlled randomized controlled trial that will start enrollment within 2 months. Patients are randomized to either the ReCET or a “sham” procedure, which means that patients undergo the same endoscopic procedure without the ReCET catheter being activated. After the procedure (either ReCET or sham) all patients will stop their insulin and will be started on semaglutide. Both the patient and the attending medical team will be blinded to the allocated treatment (ReCET or sham). At 6 months, unblinding will take place and the number of patients off insulin with adequate control of their T2D will be compared between the two groups. Patients in the sham group are offered the ReCET procedure at that time point.

Disclosures: We received an unrestricted research grant from Endogenex to conduct this study. Endogenex is the company that holds all rights on the ReCET procedure.

Citation: DDW 2023 presentation:

Re-cellularization via electroporation therapy (RECET) combined with glp-1ra to replace insulin therapy in patients with type 2 diabetes (T2D): six-month results of the EMINENT study

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Last Updated on May 4, 2023 by Marie Benz