Duodenal mucosal resurfacing offers insulin-free hope for patients with type 2 diabetes
medwireNews: Duodenal mucosal resurfacing (DMR) combined with glucagon-like peptide (GLP)-1 receptor agonists could enable some people with type 2 diabetes to discontinue insulin therapy, suggest findings from the pilot INSPIRE study.
Presenting the research at UEG Week Virtual 2020, Suzanne Meiring (Amsterdam University Medical Center, the Netherlands) explained that DMR “causes rejuvenation of the duodenal mucosa and thus restores the altered hormonal signaling.”
The endoscopic procedure involves ablation of the duodenum, takes about 45 minutes, making it less intrusive than bariatric surgery, and can be carried out by an endoscopist with sufficient training, Meiring commented.
Among 16 patients with type 2 diabetes who were included in the study, 75% had adequate glycemic control (glycated hemoglobin [HbA1c] ≤58 mmol/mol; 7.5%) without the need for insulin 6 months after undergoing a single DMR procedure.
Meiring also highlighted that despite the elimination of insulin, glycemic parameters improved significantly in patients who responded to the procedure. Insulin sensitivity increased, as indicated by HOMA-IR decreasing from an average 8.9 at baseline to 2.6 at 6 months, while fasting plasma glucose improved from 10.5 to 7.6 mmol/L (169.0 to 136.8 mg/dL).
The study participants, who were aged an average of 61 years, were all taking long-acting insulin prior to the DMR procedure, at a mean of 31 daily units of insulin, and had adequate insulin production, as indicated by a C-peptide level of at least 0.5 nmol/L. Baseline HbA1c was an average of 58 mmol/mol (7.5%), with no patient having levels above 64 mmol/mol (8.0%), and BMI was 29.2 kg/m2 on average.
The patients stopped taking their insulin on the day of the DMR procedure, while GLP-1 receptor agonist treatment was introduced after 2 weeks and increased in a stepwise fashion to a daily dose of liraglutide 1.8 mg. The patients received mild lifestyle counseling from a dietitian and were followed up every 4 to 12 weeks. If at any time a patient’s HbA1c rose above 58 mmol/mol, GLP-1 agonist treatment was stopped and insulin restarted.
Meiring noted the positive effect of the procedure on overall metabolic health, with liver fat among responders reducing significantly from an average 8.1% before the procedure to 4.6% at 6 months, which “is clinically very relevant,” she said. In addition, BMI fell from an average 29.8 kg/m2 at baseline to 27.2 kg/m2.
At 12 months, the effect of DMR had faded slightly, but the majority of patients were still off insulin at this point, at 56%, and the glycemic and metabolic effects continued to improve. Meiring commented that multiple DMRs might help to extend the effects, although this is still to be tested.
She acknowledged that the mechanism of DMR is not yet completely understood and the results from mechanistic studies are due to follow soon.
But she concluded that DMR “may be a game-changing approach in the treatment of metabolic syndrome,” and a large international trial – the Revita T2Di Pivotal study – has now been started in the USA.
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