A novel duodenal mucosal resurfacing (DMR) ablation procedure improves glycaemic control and allows many people with type 2 diabetes to discontinue insulin, according to findings presented at UEG 2020.
Researchers from the Netherland showed that the procedure which rejuvenates the lining of the duodenum to be highly effective when combined with glucagon-like peptide 1 (GLP-1) receptor agonists and lifestyle counselling.
A pilot study in 16 patients led by Dr Suzanne Meiring from the Amsterdam University Medical Center found that 75% of previously insulin-dependent people with type 2 diabetes treated with the ablation technique did not need insulin six months later.
Patients who underwent DMR ablation showed median HbA1c improvement from 7.4 to 6.7% and improvement in insulin resistance (HOMA-IR from 8.9 to 2.5, p=0.006). Similarly, liver proton density fat fraction (PDFF) improved significantly from 8.1 to 4.6%, p=0.016).
At 12 months, 56% (9/16) of patients were still off insulin therapy with a median HbA1c of 6.7 %.
Patients who responded to the procedure also saw significant reductions in their body mass index (BMI), down from an average of 29.8 kg/m2 to 25.5 kg/m2 after 12 months.
Among the non-responder patients who still needed insulin, the median insulin dose required fell by more than half (from 35 units to 17 units per day at 12 months).
Dr Meiring explained that DMR is a minimally invasive procedure that can be performed in an outpatient setting, delivered via an integrated over-the-wire catheter attached to a custom console that performs a synchronised lifting of the duodenal mucosa and then ablation of the treatment area.
The procedure, which has been postulated as an alternative to bariatric surgery, involves circumferential hydrothermal ablation of the duodenal mucosa resulting in subsequent regeneration of the mucosa. The mechanism of action is not understood, but it is believed to involves alteration of insulin sensitivity and restoration of metabolic homeostasis of gut mucosal cells to promote nutrient exclusion.
“This could be a game-changing approach in the treatment of metabolic syndrome,” said Dr Meiring.
“A single endoscopic DMR ablation with GLP-1 drugs and lifestyle counselling can lead to discontinuation of insulin therapy in a subset of patients with type 2 diabetes, while improving their blood glucose control and overall metabolic health.”
“Many patients with type 2 diabetes are very happy to be able to discontinue insulin therapy, since insulin therapy comes with weight gain and hypoglycaemic events. Our earlier study, (Revita-1) with patients that used only oral medication for their diabetes type 2, showed that the effect of a single DMR was comparable to adding one glucose lowering drug.”
She added that based on the results of the pilot study, a large international randomised controlled trial, called Revita T2Di Pivotal, will soon start to further investigate its effectiveness in greater numbers.