The procedure uses controlled electrical pulses to trigger changes to the lining of the first part of the small intestine. Research showed that this technique could allow patients with T2D to stop taking insulin while still maintaining glycemic control.
Findings from the preliminary, first-in-human study will be presented at Digestive Disease Week (DDW) 2023.
“The potential for controlling diabetes with a single endoscopic treatment is spectacular,” said Celine Busch, a PhD candidate in gastroenterology at Amsterdam University Medical Center and lead researcher of the study. “One of the biggest advantages of this treatment is that a single outpatient endoscopic procedure provides glycemic control, a potential improvement over drug treatment, which depends on patients taking their medication day in, day out.”
This early-stage study included 14 patients that underwent an endoscopic procedure that delivered alternating electrical pulses to the duodenum, the first part of the small intestine just below the stomach that leads to the jejunum. Following the hour-long procedure, patients were discharged the same day and put on a calorie-controlled liquid diet for 2 weeks. Patients then began taking the diabetes medication semaglutide, titrating up to 1 mg a week.
Semaglutide alone sometimes allows patients with T2D to quit taking insulin, though Busch noted this is only in about 20% of cases. However, in this study, 12 (86%) of the 14 patients maintained good glycemic control without insulin for a year, suggesting that the improvement is related to the procedure and not just to the semaglutide alone. The study authors are beginning work on a double-blind randomized controlled trial to test these results.
“While drug therapy is ‘disease-controlling,’ it only reduces high blood sugar as long as the patient continues taking the medication,” said Jacques Bergman, MD, PhD, professor of gastrointestinal endoscopy at Amsterdam University Medical Center and principal investigator on the study. “This one procedure is ‘disease-modifying’ in that it reverses the body’s resistance to its own insulin, the root cause of the Type-2 diabetes.”
The researchers hypothesized that chronic exposure to a high-sugar, high-caloric diet results in an unknown change to the duodenum, making the body resistant to its own insulin. They believe rejuvenating the tissue in this part of the intestine improves the body’s ability to respond to its own insulin, especially in patients with T2D whose bodies still produce some insulin.
Currently, more than 37 million Americans live with diabetes, with over 90% of them having T2D specifically. While T2D often develops in people over the age of 45, an increasing number of children, teens, and young adults are also developing it.
The development of this procedure is also important as the costs of glucose lowering medication can be expensive and insulin injections can have several side effects, including low blood sugar and weight gain. While the results of this study are preliminary, they are promising and warrant further investigation, as this new procedure could revolutionize diabetes treatment and management and provide millions of patients with an alternative to taking insulin.
The study was fully funded by Endogenex, a Minnesota-based company that owns the technology used for the endoscopic procedure. Bergman also serves on the advisory board of Endogenex.