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

中文翻译：

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用于治疗 2 型糖尿病的内窥镜十二指肠黏膜表面置换：第一项国际、开放标签、前瞻性、多中心研究的一年结果

背景 通过减肥手术的学习和具体观察，十二指肠已成为代谢治疗的目标，绕过、排除或改变十二指肠营养暴露引起有利的代谢变化。十二指肠黏膜表面重修 (DMR) 是一种新型内窥镜手术，已被证明可以改善 2 型糖尿病 (T2D) 患者的血糖控制，而不管体重指数 (BMI) 的变化如何。DMR 包括基于导管的圆周黏膜提升，然后是十二指肠黏膜的水热消融。这项多中心研究评估了 DMR 的安全性和可行性及其对 24 周和 12 个月时血糖的影响。方法 国际多中心、开放标签研究。服用稳定口服降糖药物的 T2D（HbA1c 59-86 mmol/mol (7.5%-10.0%)）患者（BMI 24-40）接受了 DMR。降糖药物在 DMR 后保持稳定至少 24 周。在随访期间，使用重复测量方差分析确定和分析 HbA1c、空腹血糖 (FPG)、体重、肝转氨酶、胰岛素抵抗稳态模型评估 (HOMA-IR)、不良事件 (AE) 和治疗满意度。邦费罗尼修正。结果共纳入46例患者，其中37例（80%）行完全DMR，36例最终分析；在其余患者中，主要观察到技术问题。24 名患者有至少 1 次与 DMR 相关的 AE (52%)。其中，81% 是轻度的。报告了 1 次 SAE 和未预料到的 AE。DMR 后 24 周 (n=36)、HbA1c (-10±2 mmol/mol (-0.9%±0.2%), p<0.001)、FPG (-1.7±0.5 mmol/L, p<0.001) 和HOMA-IR 改善（-2.9±1.1，p<0.001），体重适度降低（-2.5±0.6 kg，p<0.001），肝转氨酶水平降低。效果持续 12 个月。HbA1c 的变化与适度的体重减轻无关。糖尿病治疗满意度评分显着提高。结论 在这项多中心研究中，DMR 被发现是一种可行且安全的内窥镜手术，无论体重是否减轻，使用口服降糖药物的控制不佳的 2 型糖尿病患者都能获得持久的血糖改善。进一步检查对肝脏的影响。试验注册号 NCT02413567 结论 在这项多中心研究中，DMR 被发现是一种可行且安全的内窥镜手术，无论体重是否减轻，使用口服降糖药物的控制不佳的 2 型糖尿病患者都能获得持久的血糖改善。进一步检查对肝脏的影响。试验注册号 NCT02413567 结论 在这项多中心研究中，DMR 被发现是一种可行且安全的内窥镜手术，无论体重是否减轻，使用口服降糖药物的控制不佳的 2 型糖尿病患者都能获得持久的血糖改善。进一步检查对肝脏的影响。试验注册号 NCT02413567