A single duodenal mucosal resurfacing (DMR) procedure was well tolerated, safe, and elicits clinically and statistically significant improvements in HbA1c levels and liver fat content in patients with poorly controlled type 2 diabetes mellitus, according to REVITA-2 study.
Patients enrolled in this double-blind, superiority randomised controlled trial were those whose HbA1c level was 59–86 mmol/mol, body mass index more than 24 and less than 40 kg/m2, fasting insulin more than 48.6 pmol/L, more than 1 oral antidiabetic medication.
They were randomised (1:1) to undergo the DMR (performed with the single catheter Revitasystem) or sham procedure by using a central web-based random allocation system.
A full DMR procedure was defined as five sequential ablations of 2 axial centimetres each, starting within 3 centimetres distal to the Ampulla of Vater towards the Ligament of Treitz, totalling 10 axial centimetres of circumferentially ablated tissue in the duodenum during a single endoscopic session. The sham procedure consisted of placing the DMR catheter over the guidewire into the stomach and leaving it in place for 30 min prior to removing it from the patient.
In the overall modified intention-to-treat (mITT) population (DMR n=56; sham n=52), the median change in HbA1c from baseline at 24 weeks post procedure was
10.4 (18.6) mmol/mol in the DMR group compared with
7.1 (16.4) mmol/mol in the sham group.
In patients with baseline liver MRI proton-density fat fraction (MRI-PDFF) more than 5% (DMR n=48; sham n=43), the median absolute change in liver MRI-PDFF from baseline at 12 weeks was 5.4 in the DMR group compared with 2.9 in the sham group. In overall per protocol (PP), patients with high baseline fasting plasma glucose ((FPG) more than 10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham.
Most adverse events were mild and transient.
Based on the findings, researchers concluded that duodenal mucosal resurfacing is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high fasting plasma glucose.
“These data provide insight into a potential therapeutic opportunity for duodenal mucosal resurfacing to favourably impact both type 2 diabetes and non-alcoholic fatty liver disease/non-alcoholic steatohepatitis in a manner that can modify the natural history of these chronic and progressive diseases,” they stated.