Histologic assessment of the intestinal wall following duodenal mucosal resurfacing (DMR): a new procedure for the treatment of insulin-resistant metabolic disease

Moura, Eduardo Guimarães Hourneaux de; Neto, Alberto Machado da Ponte; Tsakmaki, Anastasia; Aiello, Vera Demarchi; Bewick, Gavin; Brunaldi, Vítor Ottoboni

doi:10.1055/a-0862-0263

Cited by 12 publications

(13 citation statements)

References 15 publications

(17 reference statements)

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“…Duodenal mucosal resurfacing (DMR) is a minimally invasive endoscopic procedure performing circumferential mucosal lift and hydrothermal ablation of the duodenal mucosa. 15 The first-in-human safety trial showed that DMR is safe and able to improve glycaemic control in proportion to the length of the ablated duodenal mucosal segment. 16 17 The following multicentre, open-label REVITA-1 trial in 46 patients with poorly controlled T2D showed a significant reduction of baseline HbA1c at 24 weeks after DMR of −10±2 mmol/mol (−0.9%±0.2%; p<0.001).…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial

Mingrone

Baar

Devière

et al. 2021

Gut

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ObjectiveHydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D).DesignEligible patients (haemoglobin A1c (HbA1c) 59–86 mmol/mol, body mass index≥24 and ≤40 kg/m2, fasting insulin >48.6 pmol/L, ≥1 oral antidiabetic medication) enrolled in Europe and Brazil. Primary endpoints were safety, change from baseline in HbA1c at 24 weeks, and liver MRI proton-density fat fraction (MRI-PDFF) at 12 weeks.ResultsOverall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was −10.4 (18.6) mmol/mol in DMR group versus −7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was −5.4 (5.6)% in DMR group versus −2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was –6.6 mmol/mol (17.5 mmol/mol) versus –3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was –5.4% (6.1%) versus –2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)≥10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient.ConclusionsDMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high FPG.Trial registration numberNCT02879383

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Section: Introductionmentioning

confidence: 99%

Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial

Mingrone

Baar

Devière

et al. 2021

Gut

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“…An additional study by de Moura et al performed histologic assessment of porcine duodenal epithelium following treatment with the Revita procedure [54]. These findings confirmed that mucosa resurfacing promotes superficial mucosal ablation of the villus tips to the crypt base while also observing that the submucosal lift creates a submucosal barrier protection against deeper tissue injury.…”

Section: Duodenal Mucosal Resurfacingmentioning

confidence: 80%

Bariatric and metabolic therapies targeting the small intestine

McCarty

Thompson

2020

Techniques and Innovations in Gastrointestinal Endoscopy

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The global prevalence of obesity and type 2 diabetes (T2DM) necessitates an increased reliance on effective and safe endoscopic therapies. While surgery is highly effective, endoscopic therapies may be able to reach a greater number of affected individuals and help to reduce the burden of disease worldwide. Although current endoscopic treatments entail space occupying gastric devices as well as suturing or plication, innovative, non-Food and Drug Administration (FDA)-approved small bowel-specific endoscopic bariatric and metabolic therapies have been developed within the last several years. Small intestine therapies include endoluminal bypass liners, duodenal mucosal resurfacing, endoscopic anastomosis systems, and restricted duodenal flow treatments. These endoscopic bariatric and metabolic therapies rely upon foregut and hindgut mechanisms to achieve weight loss and improve glucose homeostasis. This review will detail these important small bowel mechanisms and evaluate current small bowel endoscopic treatments.

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“…The duodenal mucosa is separated from the submucosal layers by injecting normal saline, followed by circumferential hypothermal ablation of the mucosal layer. 99 A direct relationship was observed between the length of the ablated duodenal segment and the improvement in metabolic profile. 100 To further study the efficacy of DMR, de Oliveira et al 101 conducted a meta-analysis embracing various metabolic variables (HbA1C, fasting plasma glucose, weight loss, liver enzymes, and hepatic steatosis).…”

Section: Management Of Obesity In Patients With Nafldmentioning

confidence: 90%

Management of Obesity and Nonalcoholic Fatty Liver Disease: A Literature Review

2021

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With the recent urbanization and globalization, the adult obesity rate has been increasing, which was paralleled with a dramatic surge in the incidence and prevalence of nonalcoholic fatty liver disease (NAFLD). NAFLD poses a growing threat to human health as it represents the most common cause of chronic liver disease in developed countries. It encompasses a wide spectrum of conditions starting from a build-up of fat in hepatocytes (steatosis), to developing inflammation (steatohepatitis), and reaching up to cirrhosis. It is also associated with higher rates of cardiovascular mortalities. Therefore, proper timely treatment is essential and weight loss remains the cornerstone in the treatment of obesity-related liver diseases. When diet, exercise, and lifestyle changes are not successful, the current recommendation for weight loss includes antiobesity medications and bariatric endoscopic and surgical interventions. These interventions have shown to result in significant weight loss and improve liver steatosis and fibrosis. In the current literature review, we highlight the expected outcomes and side effects of the currently existing options to have a weight-centric NAFLD approach.

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Histologic assessment of the intestinal wall following duodenal mucosal resurfacing (DMR): a new procedure for the treatment of insulin-resistant metabolic disease

Cited by 12 publications

References 15 publications

Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial

Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial

Bariatric and metabolic therapies targeting the small intestine

Management of Obesity and Nonalcoholic Fatty Liver Disease: A Literature Review

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