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DMR outcomes

DMR procedure improves metabolic control in T2DM

The Revita DMR device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa
Endoscopic Revita DMR procedures improves metabolic measures including hepatic transaminase levels in patients with type 2 diabetes

The latest results from the non-invasive Revita Duodenal Mucosal Resurfacing (DMR) procedure has reported that the procedure improves broader measures of metabolic control in patients with type 2 diabetes and fatty liver disease. The results showed that a single DMR treatment results included a lowering of hepatic transaminase levels, sustained through six months of follow up.

The outcomes, ‘Endoscopic duodenal mucosal resurfacing (DMR) improves metabolic measures including hepatic transaminase levels in patients with type 2 diabetes (T2D): Data from a first-in-human study,’ were announced at the 2016 International Liver Conference of the European Association for the Study of Liver (EASL) in Barcelona, Spain. 

The Revita DMR device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa

After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum

Endoscopic DMR is a minimally-invasive procedure designed to safely alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The procedure is an endoscopic procedure that thermal ablates the duodenal mucosa.

Fractyl Laboratories, the company behind the DMR technology, claims the procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed.

Study

The study performed by researchers from the Gastro Obeso Center, São Paulo, Brazil, the Florida International University, Miami, Florida, USA and the Clinical Center for Diabetes, Obesity and Reflux, Santiago, Chile, evaluated the effect of DMR on metabolic parameters and assessed procedural safety in patients with sub-optimally controlled T2DM (HbA1c >7.5% on ≥1 anti-diabetic agent)

Using novel balloon catheters, Revita DMR System (Fractyl Laboratories), they performed thermal ablation on varying lengths of duodenum in anesthetised patients with sub-optimally controlled T2DM. The procedures, performed by trained endoscopists at a single medical centre (Santiago, Chile),

They enrolled 44 consecutive patients and 39 patients were treated (four patients did not receive DMR (two failed screening endoscopy, one tortuous anatomy, one had procedure stopped prior to ablation to prevent prolonged anaesthesia), and one patient was excluded for anti-GAD+, indicative of type 1 diabetes, after index procedure). The patients has a mean age of 53.3 years and a mean BMI30.9±3.5. Twenty eight patients received a long-segment DMR (LS ablation length 9.3cm) and 11 received short segment DMR (SS: ablation length 3.4cm).

Procedural included duodenal sizing, lifting of mucosa using saline and circumferential hydrothermal ablation of superficial mucosa to stimulate regeneration. All patients were given a post-treatment, two-week low calorie, graduated diet (liquids, then soft puree). There was no specific recommendation on post-procedure management of anti-diabetic medication.

The procedure was well tolerated with minimal GI symptoms, and three duodenal stenoses were identified and resolved with endoscopic balloon dilation. There were no GI bleeds, perforation, pancreatitis, malabsorption or incidents of hypoglycaemia. Follow up endoscopy indicated full mucosal healing at one month.

The outcomes revealed that the DMR procedures resulted in a reduction in HbA1c%, Aspartate aminotransferase (AST) - IU/L and Alanine transaminase (ALT) ALT – IU/L from baseline out to six months. There was no apparent correlation between weight loss and glycaemic improvement (Table 1). Interestingly, there was a more effective glycaemic effect observed among LS cohort (not shown).

Table 1: Changes (mean±SD) in metabolic parameters in long segment DMR cohort

Overall, the researchers said that the DMR improves metabolic control in T2DM patients, including a robust and sustained lowering of hepatic transaminase levels, suggesting favourable end-organ hepatic effect. They believe that DMR offers the potential for a single-point intervention that improves both glycaemia and fatty liver, although further study in patients with T2DM and fatty liver disease is warranted.

The study was funded by Fractyl Laboratories. The DMR System received European CE Mark approval in April 2016

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