HealthDay News — Single-procedure duodenal mucosal resurfacing (DMR) is effective for reducing glycated hemoglobin (HbA1c) in patients with type 2 diabetes, according to a study published online in Diabetes Care.
Harith Rajagopalan, MD, PhD, from Fractyl Laboratories Inc. in Waltham, Mass., and colleagues used novel balloon catheters to conduct DMR on varying lengths of duodenum in anesthetized patients with type 2 diabetes. Twenty-eight patients had a long duodenal segment (LS) ablated, and 11 had a short segment (SS) ablated.
The researchers found that DMR was well tolerated with minimal post-procedure gastrointestinal symptoms. Duodenal stenosis was experienced by 3 patients, who were treated successfully by balloon dilation. In the full cohort, HbA1c was reduced by 1.2% at 6 months (P<.001). The LS cohort had a more potent glycemic effect, with 2.5% reduction in mean HbA1c versus 1.2% in the SS group (P<.05) at 3 months postprocedure and 1.4% vs 0.7% reduction in HbA1c at 6 months (P=.3). HbA1c was reduced by 1.8% at 6 months among LS patients with a screening HbA1c of 7.5% to 10% and on stable antidiabetic medications postprocedure.
“Single-procedure DMR elicits a clinically significant improvement in hyperglycemia in patients with type 2 diabetes in the short-term, with acceptable safety and tolerability,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Fractyl Laboratories, which funded the study.
- Rajagopalan H, Cherrington AD, Thompson CC, et al. Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study. Diabetes Care. 2016; doi: 10.2337/dc16-0383