Endoscopic Duodenal Mucosal Resurfacing Research Articles

Endoscopic duodenal mucosal resurfacing for treating obesity and metabolic diseases: State-of-the-art review

Endoscopic duodenal mucosal resurfacing for treating obesity and metabolic diseases: State-of-the-art review

Bariatric endoscopy: from managing complications to primary metabolic procedures.

Obesity is a worldwide epidemic and is the second leading cause of preventable death. The approach to treating obesity involves a multidisciplinary approach including lifestyle interventions, pharmacological therapies, and bariatric surgery. Endoscopic interventions are emerging as important tools in the treatment of obesity with primary and revisional bariatric endoscopic therapies. These include intragastric balloons, aspiration therapy, suturing and plication, duodenal-jejunal bypass liners, endoscopic duodenal mucosal resurfacing, and incisionless magnetic anastomosis systems. Endoscopic interventions have also demonstrated efficacy in treating complications of bariatric surgery. Approaches include stenting, endoscopic internal drainage, and endoscopic vacuum-assisted closure. This review aimed to discuss the current endoscopic procedures used as primary and revisional bariatric therapy including those used for managing bariatric surgical complications.

Metabolic Effects of Endoscopic Duodenal Mucosal Resurfacing: a Systematic Review and Meta-analysis.

Duodenal mucosal resurfacing (DMR) is an innovative endoscopic bariatric and metabolic therapy (EBMT) emerging in recent years. It uses the duodenum to achieve better glycemic and weight control. This study aimed to evaluate in a critical and systematic way the metabolic effects of this procedure. Electronic searches were performed evaluating the DMR procedure based on predefined inclusion and exclusion criteria. Changes in measured outcomes were evaluated using random-effects models by computing weighted mean differences (MD) and corresponding 95% CIs between pre-and post-procedure metabolic characteristics. Four studies were selected for qualitative and quantitative analysis. DMR demonstrated beneficial glycemic and hepatic metabolic effects among patients with non-insulin dependent type 2 diabetes (T2D) at 3 and 6months post-procedure.

Endoscopic duodenal mucosal resurfacing improves glycaemic and hepatic indices in type 2 diabetes: 6-month multicentre results.

Background & AimsInsulin resistance is a core pathophysiological defect underscoring type 2 diabetes mellitus (T2DM) and non-alcoholic fatty liver disease (NAFLD). Both conditions improve with duodenal exclusion surgery. Duodenal mucosal resurfacing (DMR) is an endoscopic intervention developed to treat metabolic disease which has been shown to improve glycaemia in patients with poorly controlled T2DM. Herein, we aimed to further analyse the effects of DMR on hepatic and metabolic parameters in this patient cohort.MethodsEighty-five patients with T2DM who received endoscopic DMR treatment were enrolled from 5 centres and followed up for 6 months. We assessed safety in all patients. Efficacy was evaluated in patients who received at least 9 cm of duodenal ablation (n = 67). Endpoints included HbA1c, fasting plasma glucose, weight and aminotransferase levels. Metabolomic analysis was conducted in a subgroup (n = 14). Data were analysed using paired t test or ANOVA for repeated measures with Bonferroni correction and correction for initial weight loss if applicable.ResultsThe DMR procedure was completed with no intraprocedural complications in the entire cohort. HbA1c was lower 6 months after DMR than at baseline (7.9 ± 0.2% vs. 9.0 ± 0.2% [mean ± SE], p ≪0.001). Fasting plasma glucose was also significantly lower 6 months after DMR compared to baseline (161 ± 7 mg/dl vs. 189 ± 6 mg/dl, p = 0.005). Body weight decreased slightly. At 6 months, alanine aminotransferase had decreased from 41 ± 3 IU/L to 29 ± 2 IU/L (p ≪0.001) and aspartate aminotransferase had decreased from 30 ± 2 IU/L to 23 ± 1 IU/L (p ≪0.001). Metabolomic analysis demonstrated that DMR had key lipid-lowering, insulin-sensitizing and anti-inflammatory effects, as well as increasing antioxidant capacity. Mean FIB-4 was also markedly decreased.ConclusionHydrothermal ablation of the duodenum by DMR elicits a beneficial metabolic response in patients with T2DM. DMR also improves hepatic indices, potentially through an insulin-sensitizing mechanism. These encouraging data deserve further evaluation in randomized controlled trials.Lay summaryHydrothermal duodenal mucosal resurfacing (DMR) is an endoscopic technique designed to treat metabolic disease through ablation of the duodenal mucosa. DMR is a safe procedure which improves glycaemia and hepatic indices in patients with type 2 diabetes mellitus. DMR is an insulin-sensitizing intervention which can be complementary to lifestyle intervention approaches and pharmacological treatments aimed at preserving the pancreas and liver from failure. DMR is a potential therapeutic solution for patients with type 2 diabetes and fatty liver disease.

Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study

BackgroundThe duodenum has become a metabolic treatment target through bariatric surgery learnings and the specific observation that bypassing, excluding or altering duodenal nutrient exposure elicits favourable metabolic changes. Duodenal mucosal...

1156-P: Duodenal Mucosal Resurfacing (DMR) Combined with GLP-1 RA May Eliminate Insulin Therapy and Improve Metabolic Health in Type 2 Diabetes

Background: Duodenal mucosal resurfacing (DMR) is an endoscopic intervention in which the duodenal mucosa is ablated by hydrothermal energy. DMR improves glycemic control in type 2 diabetes (T2D) through altered metabolic signaling from the duodenum causing insulin sensitization. We studied the feasibility of eliminating insulin therapy in T2D by combining DMR with GLP-1r agonism (liraglutide) and lifestyle counseling. Methods: Single arm, single center study in 16 insulin treated T2D patients (HbA1c ≤64 mmol/mol; basal insulin <1U/kg/day, c-peptide ≥0.5 nmol/l). Day 1, DMR is administered and insulin therapy discontinued. Day 14, liraglutide is introduced (titrated to 1.8 mg/day) and life style counseling is administered throughout. Primary endpoint: percentage of patients free of insulin and HbA1c ≤59 mmol/mol at 6 months. Results: Enrolment has been completed and 9 patients have reached 6 months with 8/9 (89%) insulin-free and able to maintain glycemic control with improvement across multiple metabolic parameters (Table 1). Conclusion: Single endoscopic DMR, combined with liraglutide and lifestyle counseling, may effectively eliminate the need for insulin therapy in T2D while improving overall metabolic health. This treatment approach is a promising alternative that appears to shift insulin-treated T2D patients to a state of better overall metabolic health. Disclosure P. Smeele: None. A.C. van Baar: None. T.M. Vriend: None. F. Holleman: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Sanofi. M. Soeters: None. M. Nieuwdorp: Advisory Panel; Self; Caelus health. J. Tijssen: None. J.J. Bergman: Research Support; Self; Fractyl Laboratories, Inc.

Ablation of the Duodenal Mucosa as a Strategy for Glycemic Control in Type 2 Diabetes: Role of Nutrient Signaling or Simple Weight Loss.

As our understanding of the pathophysiology of type 2 diabetes (T2D) has advanced, new oral and injectable medications have been developed that target a growing number of the pathophysiological processes that cause hyperglycemia. In addition, weight-loss therapy, involving lifestyle interventions, antiobesity medications, or bariatric surgery, has been demonstrated to be highly effective in T2D management. The expanded number of treatment options has provided an increased capacity for glycemic control. Even so, T2D remains a progressive disease, requiring the intensification of therapy over time, and many patients still do not achieve HbA1c targets. Therefore, new therapeutic strategies for effective and safe glycemic control are critically needed. In this issue of Diabetes Care , Rajagopalan et al. (1) present a new therapeutic strategy for treatment of T2D. The strong point of the study is that the authors have developed and studied a novel therapeutic approach in T2D that could elucidate new disease mechanisms involving the role of the duodenum in metabolic regulation. The authors present a 6-month interim analysis of a phase I, single-arm, nonrandomized cohort study assessing safety and efficacy of endoscopic duodenal mucosal resurfacing (DMR) for treatment of T2D. This is a first-in-human experience with this intervention, which ablates the duodenal mucosa between the ampulla of Vater and the ligament of Treitz in a two-step endoscopic procedure. First, a catheter with a terminal balloon is passed into the duodenum that has three needles spaced at 120° around the balloon’s circumference. The needles are used to inject saline into the submucosal space in order to circumferentially separate and lift the mucosa from underlying tissues in the duodenal wall. A second catheter then introduces another balloon that thermally ablates (i.e., burns) the lifted mucosa at a temperature of ∼90°C (194°F). The conceptual basis of the procedure is derived from observations that …

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study

To assess procedural safety and glycemic indices at 6 months in a first-in-human study of duodenal mucosal resurfacing (DMR), a novel, minimally invasive, upper endoscopic procedure involving hydrothermal ablation of the duodenal mucosa, in patients with type 2 diabetes and HbA1c ≥7.5% (58 mmol/mol) on one or more oral antidiabetic agents. Using novel balloon catheters, DMR was conducted on varying lengths of duodenum in anesthetized patients at a single medical center. A total of 39 patients with type 2 diabetes (screening HbA1c 9.5% [80 mmol/mol]; BMI 31 kg/m2) were treated and included in the interim efficacy analysis: 28 had a long duodenal segment ablated (LS; ∼9.3 cm treated) and 11 had a short segment ablated (SS; ∼3.4 cm treated). Overall, DMR was well tolerated with minimal gastrointestinal symptoms postprocedure. Three patients experienced duodenal stenosis treated successfully by balloon dilation. HbA1c was reduced by 1.2% at 6 months in the full cohort (P < 0.001). More potent glycemic effects were observed among the LS cohort, who experienced a 2.5% reduction in mean HbA1c at 3 months postprocedure vs. 1.2% in the SS group (P < 0.05) and a 1.4% reduction at 6 months vs. 0.7% in the SS group (P = 0.3). This occurred despite net medication reductions in the LS cohort between 0 and 6 months. Among LS patients with a screening HbA1c of 7.5-10% (58-86 mmol/mol) and on stable antidiabetic medications postprocedure, HbA1c was reduced by 1.8% at 6 months (P < 0.01). Single-procedure DMR elicits a clinically significant improvement in hyperglycemia in patients with type 2 diabetes in the short-term, with acceptable safety and tolerability. Long-term safety, efficacy, and durability and possible mechanisms of action require further investigation.

FRI-300 - 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

FRI-300 - 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