August 18, 2016
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Duodenal mucosal resurfacing confers short-term benefits in type 2 diabetes

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Adults with type 2 diabetes have significantly improved hyperglycemia in the short term after single-procedure duodenal mucosal resurfacing, published data show.

Harith Rajagopalan, MD, PhD, co-founder, CEO and director of Fractyl Laboratories Inc., and colleagues evaluated 39 adults with type 2 diabetes who underwent duodenal mucosal resurfacing using novel balloon catheters on varying lengths of duodenum to determine the procedural safety and glycemic indices at 6 months.

Ablation of a long segment of duodenal mucosal was performed in 28 participants and 11 had a short segment ablated.

Immediately after the procedure and at later follow-up visits, there was no gastrointestinal bleeding, perforation, pancreatitis, severe hypoglycemia or evidence of malabsorption. Transient postprocedural abdominal pain due to air insufflation and/or endotracheal intubation was the most common study-related adverse event. Discomfort was not reported by any participants by 48 hours after the procedure.

At 6 months, HbA1c was reduced by 1.2% in all participants (P < .001). At 3 months, the long segment of duodenal mucosal resurfacing group had a 2.5% reduction in mean HbA1c compared with a mean reduction of 1.2% in the short segment duodenal mucosal resurfacing group (P < .05 between groups). At 6 months, the trend continued in both groups (long segment, 1.4%; short segment, 0.7%; P = .3 between groups).

“Our findings suggest that minimally invasive upper gastrointestinal intervention through [duodenal mucosal resurfacing] can improve glycemia in type 2 diabetes and represents an interesting potential adjuvant or alternative to pharmacological treatment,” the researchers wrote. “The [duodenal mucosal resurfacing] approach may overcome treatment adherence and compliance issues, a major shortcoming of all pharmacological approaches. [Duodenal mucosal resurfacing] also provides a window into the intriguing and specific role of the duodenum in regulating downstream metabolism. Further work is necessary to better understand the clinical utility of this procedure-based intervention in controlled trial conditions in larger numbers of patients.” – by Amber Cox

Disclosure: Rajagopalan reports being an employee and owning shares in Fractyl Laboratories Inc.