BACKGROUND AND AIMS
Duodenal mucosal resurfacing (DMR) is an endoscopic intervention in which the duodenal mucosa is ablated by hydrothermal energy. DMR improves glycemic control in patients with type 2 diabetes (T2D), most likely by altered duodenal signaling leading to insulin sensitization. We studied whether we could discontinue insulin use in T2D patients by combining DMR with glucagon-like peptide-1 receptor agonism (GLP-1RA) and lifestyle counseling.
Single-arm, single-center feasibility study in 16 insulin treated T2D patients (HbA1c ≤8.0%; basal insulin <1U/kg/day, c-peptide ≥0.5 nmol/L). Patients underwent a single DMR followed by a 2-week postprocedural diet, after which GLP-1RA (liraglutide) was introduced. Lifestyle counseling was provided per ADA guidelines. The primary endpoint was percentage of patients without insulin with an HbA1c ≤7.5% (responders) at 6 months. Secondary endpoints were changes in multiple glycemic and metabolic parameters and percentage of responders at 12 and 18 months, respectively.
All 16 patients underwent successful DMR without procedure-related serious adverse events. At 6 months, 69% of patients were off insulin therapy with an HbA1c ≤7.5%. At 12 and 18 months 56% and 53% remained off insulin, respectively. All patients significantly improved in glycemic and metabolic parameters: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), BMI, weight, and liver fat fraction.
n this feasibility study, the combination of a single DMR and GLP-1RA, supported by lifestyle counselling eliminated the need for insulin therapy in the majority of patients with T2D through 18 months postprocedure, with adequate beta-cell capacity, while improving glucose regulation and metabolic health in all patients. A randomized-sham controlled trial is currently initiated based on these results.