Duodenal Mucosal Resurfacing as a Treatment Option for Type 2 Diabetes 

Duodenal mucosal resurfacing is a new, less invasive take on bariatric surgery that may hold promise in the treatment of type 2 diabetes.  

Bariatric surgery has been increasingly used in patients with class I, II, and III obesity. While bariatric surgery is an effective way to help aid glycemic control, with increasing rates of diabetes and obesity, bariatric surgery may not be scalable, as most procedures are invasive and have some morbidity. It has been suggested that changing how nutrients are presented to the duodenum is one reason why improvements are seen after bariatric surgery. Importantly, this alteration does not appear to lead to malabsorption of nutrients. The ease of access to the duodenum makes it an attractive target for potential interventions. The endoscopic duodenal mucosal resurfacing in this study was performed using catheters that were advanced using guidewires alongside the endoscope. This procedure is a minimally invasive procedure where the duodenal mucosa is ablated using a heated liquid, encouraging the mucosa to regenerate.  

Where past studies adjusted diabetic medications alongside the procedure, this international, multi-center, prospective, open-label study recruited only participants on a stable medication regimen to ensure the improved glycemic results were from the endoscopic duodenal mucosal resurfacing and not from changing the medication regimen. The authors sought to prove safety as well as the efficacy of the procedure. The study participants were those with type 2 diabetes, aged 28-75, with a BMI of 24-40, an HbA1c of 7.5-10%, and on a stable oral medication regimen. For the procedure, participants were placed under general anesthesia or deep sedation using propofol, depending on the local hospital’s policy. The ablation was performed over a 9-10 cm section of the postpapillary duodenum. Four acetaminophens were given to patients after the procedure if needed. Patients were either kept overnight or discharged the same day, again, per each hospital’s guidelines. Post-procedure, there was a two-week diet where clear liquids were slowly changed to solid foods. After those two weeks and throughout the twelve-month follow-up, only standard dietary counseling was provided. 

In the patients who were enrolled, sulfonylureas and meglitinides were discontinued to decrease the chances of possible hypoglycemic adverse events. All participants had a four-week run-in phase to monitor blood glucose levels and to check their compliance – any patients that had multiple hypos- or hyper-glycemic events were excluded from further participation. Adverse events from the duodenal mucosal resurfacing were classified as mild, moderate, or severe. Mild adverse effects included discomfort with no interruption of daily activity, moderate adverse effects included discomfort terrible enough to impact daily activity, and severe adverse effects included the inability to perform the daily activity.  

Of the 46 accepted patients, 37 completed the duodenal mucosal resurfacing. Two of these patients reported an adverse effect. 56% of these adverse events were possibly related to the procedure, 30% were probably related, and 15% were associated with the procedure. 41% of the adverse events were treated with medications. Of the participants, only 3 reported hypoglycemic events, none of which were severe enough to require help from a third party. After the procedure, the HbA1c was lowered by an average of 0.9% at 24 weeks (P < 0.001), which remained at 12 months. There was weight loss seen at four weeks after the procedure, after which time weight remained stable. This weight loss may be due to the change in diet immediately following the procedure. Additionally, it was found that alanine transaminase decreased from 40 to 31 at 24 weeks (P = 0.016) and 30 at 12 months (P < 0.001). Patient’s diabetes treatment satisfaction improved after the procedure compared to their baseline satisfaction (P = 0.002), while perceived hyper- and hypo-glycemia did not change significantly.  

The results of this study support endoscopic duodenal mucosal resurfacing as a feasible, safe, and effective treatment in patients with type 2 diabetes that are not adequately controlled using oral glucose-lowering medications. The benefits of this procedure extended beyond a decrease in HbA1c, as patients also saw a reduction in liver transaminase levels as well as a reduction in weight and an increase in how satisfied they were with their diabetic treatment. While the study was international, it was focused in Europe among hospitals that have doctors who specialize in these procedures. It may be harder to implement in areas where such doctors are not as readily accessible. There was no mention of cost in the study. The cost of the procedure may limit the procedure’s usefulness in the United States. 

Practice Pearls: 

• Endoscopic duodenal mucosal resurfacing isa practical, relatively safe option in the treatment of sub-optimally controlled type 2 diabetes.  
• A majority of patients (52%) experienced at least one adverse event, though 81% of those were mild. 
• The mean HbA1c decrease at 12 months post duodenal mucosal resurfacing was 0.9%. 

Baar, Annieke C G van, et al. “Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes Mellitus: One Year Results from the First International, Open-Label,  Prospective, Multicentre Study.” Gut, BMJ Publishing Group, 1 Feb. 2020,  gut.bmj.com/content/69/2/295. 

George McConnell, PharmD. Candidate, LECOM School of Pharmacy  

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