Outpatient endoscopic procedure ‘may be a game changer’ for type 2 diabetes management
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A novel endoscopic procedure combined with semaglutide may eliminate the need for insulin while improving glycemic control and metabolic parameters among patients with type 2 diabetes.
“Type 2 diabetes is typically treated by a variety of drugs with insulin therapy as the final resort,” Jacques Bergman, MD, PhD, professor of gastrointestinal endoscopy and head of endoscopy at Amsterdam University Medical Center, said during the Digestive Disease Week media briefing. “However, there are several barriers with this treatment including the fact that medication can be expensive, insulin injections can have side effects such as low blood sugar and weight gain, and drug therapy requires patients to take the medication day in, day out.”
Bergman continued: “To address this, our research explored the use of endoscopic treatment and intervening with patients with type 2 diabetes with a new procedure known as Re-Cellularization via Electroporation Therapy — the ReCET procedure.”
In a single arm, first-in-human study, researchers assessed the safety, feasibility and efficacy of the ReCET procedure — which uses electroporation to elicit cell apoptosis and renewal while also preserving tissue structure —combined with a GLP-1 receptor agonist to eliminate the need for insulin treatment in select patients with type 2 diabetes.
Fourteen patients aged 28 to 75 years (BMI 24-20 kg/m2, HbA1c 8%, basal insulin dose < 1 U/kg/day, C-peptide 0.2 nmol/L) underwent the endoscopic ReCET procedure, followed by a calorie-controlled liquid diet for 2 weeks. Participants were then started on the GLP-1 receptor agonist semaglutide, titrated up to 1 mg per week.
Researchers assessed procedure time, technical success rate, percentage of patients tolerating semaglutide, adverse events and hypoglycemic events. The primary efficacy endpoint was the number of patients off insulin at 6 months with an HbA1c of 7.5% or less.
At 6-months follow-up, the ReCET procedure had a technical success rate of 100% with a median axial treatment length of 12 cm. Procedure time was 58 minutes and 93% of patients tolerated the maximum dosage of semaglutide.
Further, 86% of patients were no longer on insulin and demonstrated “significant improvement” in glycemic control for a year; metabolic health, including more than 50% reduction in liver fat; and treatment satisfaction. Researchers reported no device-related serious adverse events.
“This may be a game changer in the management of type 2 diabetes, because a single outpatient endoscopic intervention actually was suggested to have a pretty long therapeutic effect which is compliance-free, as opposed to drug therapy that relies on patients taking their drugs on a daily basis,” Bergman said. “More importantly, this technique is disease modifying so it goes to the root cause of type 2 diabetes and tackles the insulin resistance as opposed to drug therapy which, at best, is disease controlling of which the effect is immediately gone if you stop your medication.”
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John Vargo, MBA, MPH, MASGE
Bergman and colleagues presented data on the treatment of insulin-dependent type 2 diabetes with a combination of catheter-based, endoscopically guided duodenal electroporation and the GLP-1 receptor agonist semaglutide. Electroporation is the application of an electric field to create hyperpermeability of the targeted cells, while at the same time preserving tissue stricture. Classically the technique is utilized to allow for the transfer of drugs or genetic material into the cells, but in this application, it is used to induce apoptosis, which will lead to the generation of new cells and a “rebooting” of what is theorized to be a dysfunctional duodenal component of glucose regulatory milieu.
Of the 14 patients studied, there was 100% technical success and no significant device-related adverse events. Eighty-six percent did not require the use of insulin, and there was a substantial reduction in hepatic fat burden. However, it is important to emphasize that the size of the study may limit any commentary on safety. The long-term durability of the response and whether the GLP-1 receptor agonist is necessary on an extended basis will be answered with further follow-up and future randomized, sham-controlled, single-blinded studies.
This is an exciting development: an endoscopic-pharmacologic approach to type 2 diabetes with most patients freed from the burden, potential risks and expense of daily insulin therapy. We look forward to long-term data and larger studies to validate these results.
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Busch C, et al. Abstract 1272: Re-cellularization via electroporation therapy (ReCET) combined with GLP-1RA to replace insulin therapy in patients with type 2 diabetes: 6 months results of the EMINENT Study. Presented at: Digestive Disease Week; May 6-9, 2023; Chicago (hybrid meeting).
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