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Duodenal mucosal resurfacing: proof-of-concept, procedural development, and initial implementation in the clinical

Rehan J Haidry1, Annieke C van Baar2, Manoel P Galvao Neto3

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Summary

Duodenal mucosal resurfacing (DMR) is a new endoscopic hydrothermal ablation procedure that shows promise for treating insulin resistance and type 2 diabetes. Early studies indicate improved glycemic and hepatic measures with safe mucosal healing.

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Area of Science:

  • Gastroenterology
  • Metabolic disease research
  • Endoscopic therapeutics

Background:

  • Insulin-resistant metabolic diseases, including type 2 diabetes (T2D), represent a significant global health challenge.
  • Current treatments often have limitations, necessitating novel therapeutic approaches.

Purpose of the Study:

  • To develop and evaluate duodenal mucosal resurfacing (DMR), a minimally invasive endoscopic hydrothermal ablation, for treating insulin-resistant metabolic diseases.
  • Assess the safety and efficacy of DMR in preclinical models and a first-in-human study for type 2 diabetes.

Main Methods:

  • Proof-of-concept studies in rodents and safety studies in pigs were conducted.
  • An open-label, first-in-human study evaluated DMR safety and efficacy in patients with type 2 diabetes.

Main Results:

  • Rodent studies showed DMR reduced hyperglycemia.
  • Pig studies demonstrated safe hydrothermal ablation delivery and complete mucosal healing by 6 weeks.
  • The first-in-human study confirmed safe DMR administration with no serious adverse events. Patients showed improved glycemic and hepatic measures at 6 months, with full mucosal regrowth and minimal collagen deposition.

Conclusions:

  • Duodenal mucosal resurfacing (DMR) is a potentially effective endoscopic intervention for improving glycemic and hepatic parameters in type 2 diabetes patients.
  • Further research is ongoing to fully elucidate DMR's therapeutic potential for metabolic diseases.