A novel out-patient procedure helped to improve blood glucose levels, liver insulin sensitivity, and other metabolic measures in people with poorly controlled type 2 diabetes, researchers reported last night.
The procedure centres on "resetting" the duodenum, reducing insulin resistance, developers say.
Research, which was due to be presented at the Endocrine Society’s now cancelled annual meeting, found that patients who were treated with Revita duodenal mucosal resurfacing (DMR), a novel, minimally invasive, endoscopic procedure, showed the improvements up to three months later.
The REVITA-2 study, a randomised, sham-controlled clinical trial, has helped researchers verify the insulin sensitising mechanism by which hydrothermal ablation of the duodenum improves blood sugar in patients with type 2 diabetes.
Dr David Hopkins, director of the Institute of Diabetes, Endocrinology and Obesity, King’s Health Partners in London, UK, said: “This out-patient procedure is being studied as the first disease-modifying therapy for type 2 diabetes and has thus far been demonstrated to be safe, effective, and durable through at least two years of follow up.”
The research team explored the insulin-sensitising mechanisms underlying the previously reported beneficial effects of the Revita DMR therapy.
The technology involves inserting a balloon catheter through the mouth and into the duodenum to precisely deliver thermal energy to the duodenal lining. Once treated, the damaged duodenal lining is flushed out, and a new mucosal layer begins to regenerate.
Dr Hopkins said: “The thickening of the duodenal mucosa occurs early in diabetes and may initiate changes in hormonal signalling that lead to insulin resistance, the main factor leading to type 2 diabetes.
“By resurfacing the mucosa with the Revita DMR technique and effectively resetting this signalling, we are able to demonstrate a reduction of the insulin resistance underlying diabetes and associated metabolic complications.”
The researchers analysed data from 70 patients (blinded: 35 treated; 35 sham) who had a meal tolerance test before and 12 weeks after a single endoscopic procedure. The patients’ blood glucose levels were measured before the test, while fasting, and afterwards.
The patients who received Revita DMR had a significantly improved glucose response and had improved liver measures.
Although the average fasting glucose level dropped by only 15mg/dL in the sham group, it fell by 41 mg/dL in the DMR-treated group.
Dr Hopkins said: “These findings confirm that the duodenum is an important therapeutic target for type 2 diabetes.
“The Revita treatment has the potential to transform the lives of patients who cannot adequately control their disease with drug therapies or who are interested in a non-drug treatment alternative that targets the root cause of metabolic disease.”
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