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

ABSTRACT: Insulin 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. Methods:Eighty-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. Results:The 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. Conclusion:Hydrothermal 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 summary:Hydrothermal 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.

SUBMITTER: van Baar ACG

PROVIDER: S-EPMC7005649 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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

van Baar Annieke C G ACG Beuers Ulrich U Wong Kari K Haidry Rehan R Costamagna Guido G Hafedi Alia A Deviere Jacques J Ghosh Soumitra S SS Lopez-Talavera Juan Carlos JC Rodriguez Leonardo L Galvao Neto Manoel P MP Sanyal Arun A Bergman Jacques J G H M JJGHM

JHEP reports : innovation in hepatology 20191105 6

Insulin 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 coho ...[more]

PMID: 32039394

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Project description:BACKGROUND:The 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 resurfacing (DMR) is a novel endoscopic procedure that has been shown to improve glycaemic control in people with type 2 diabetes mellitus (T2D) irrespective of body mass index (BMI) changes. DMR involves catheter-based circumferential mucosal lifting followed by hydrothermal ablation of duodenal mucosa. This multicentre study evaluates safety and feasibility of DMR and its effect on glycaemia at 24 weeks and 12 months. METHODS:International multicentre, open-label study. Patients (BMI 24-40) with T2D (HbA1c 59-86?mmol/mol (7.5%-10.0%)) on stable oral glucose-lowering medication underwent DMR. Glucose-lowering medication was kept stable for at least 24 weeks post DMR. During follow-up, HbA1c, fasting plasma glucose (FPG), weight, hepatic transaminases, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), adverse events (AEs) and treatment satisfaction were determined and analysed using repeated measures analysis of variance with Bonferroni correction. RESULTS:Forty-six patients were included of whom 37 (80%) underwent complete DMR and 36 were finally analysed; in remaining patients, mainly technical issues were observed. Twenty-four patients had at least one AE (52%) related to DMR. Of these, 81% were mild. One SAE and no unanticipated AEs were reported. Twenty-four?weeks post DMR (n=36), HbA1c (-10±2?mmol/mol (-0.9%±0.2%), p<0.001), FPG (-1.7±0.5?mmol/L, p<0.001) and HOMA-IR improved (-2.9±1.1, p<0.001), weight was modestly reduced (-2.5±0.6?kg, p<0.001) and hepatic transaminase levels decreased. Effects were sustained at 12 months. Change in HbA1c did not correlate with modest weight loss. Diabetes treatment satisfaction scores improved significantly. CONCLUSIONS:In this multicentre study, DMR was found to be a feasible and safe endoscopic procedure that elicited durable glycaemic improvement in suboptimally controlled T2D patients using oral glucose-lowering medication irrespective of weight loss. Effects on the liver are examined further. TRIAL REGISTRATION NUMBER:NCT02413567.

Dataset Information

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

Publications

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

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