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首页> 美国卫生研究院文献>Journal of the Endocrine Society >OR30-07 Mixed Meal Tolerance Test (MMTT) Results from Revita-2 the First Randomized Sham-Controlled Double-Blind Prospective Multicenter Study of Duodenal Mucosal Resurfacing (DMR) Safety and Efficacy in Patients with Sub-Optimally Controlled Type 2 Diabetes (T2D)
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OR30-07 Mixed Meal Tolerance Test (MMTT) Results from Revita-2 the First Randomized Sham-Controlled Double-Blind Prospective Multicenter Study of Duodenal Mucosal Resurfacing (DMR) Safety and Efficacy in Patients with Sub-Optimally Controlled Type 2 Diabetes (T2D)

机译：OR30-07混合膳食耐受试验（MMTT）来自Revita-2第一个随机假控双盲前瞻性多中心研究十二指肠粘膜Resurfacing（DMR）的患者患者的安全性和有效性2糖尿病（T2D）

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BACKGROUND: The duodenum is a key metabolic signaling center and regulator of metabolic homeostasis. Duodenal mucosal hyperplasia is therefore a potential therapeutic target for metabolic diseases related to insulin-resistance. Previous reports demonstrated that DMR, a minimally invasive, endoscopic mucosal ablative procedure, safely improves hepatic and glycemic parameters. Primary endpoints from REVITA-2, the first randomized, sham-controlled, double-blind, prospective, multicenter study of DMR safety and efficacy in patients with T2D, were met and previously reported. Here we further explore mechanisms underlying the beneficial effects of DMR on hepatic and glucose metabolism by analyzing mixed meal tolerance test (MMTT) data from the REVITA-2 study. Methods: Eligible patients (HbA1c 7.5–10%, BMI ≥ 24 to ≤ 40 kg/m2, on stable treatment with ≥1 oral anti-diabetic medication) received DMR or sham procedure (1:1). Exploratory endpoints included median change in fasting plasma glucose (FPG), MMTT glucose area under the curve (AUC) over 2 hours, and change in MMTT C-peptide and glucagon over 2 hours, from baseline to 12 weeks post-DMR. One-sided P value based on ANCOVA model on ranks without imputation assessed treatment difference at the 0.05 significance level. The modified intent to treat primary analysis population included randomized patients in whom study procedure was attempted. Results: A total of 70 patients (DMR, N = 35; sham, N = 35) were included in the analysis, of which 57% and 54% (DMR, n = 20; sham, n = 19) had baseline FPG ≥ 180 mg/dL. Median MMTT AUC for glucose was significantly reduced post-DMR (-36.38 mg/dL) compared with sham (-4.94 mg/dL; P = 0.009), driven by a significant decrease in FPG (DMR, -41.0 mg/dL; sham, -15.0 mg/dL; P = 0.003) rather than median MMTT postprandial glucose excursion (DMR, -4.63 mg/dL; sham, 5.34 mg/dL; P = 0.209). AUC glucose reductions were more pronounced in patients with baseline FPG ≥ 180 (DMR, -63.03 mg/dL; sham, -20.31 mg/dL; P = 0.007) compared with baseline FPG < 180 (DMR, -26.81 mg/dL; sham, 13.81 mg/dL; P = 0.271). In patients with baseline FPG ≥ 180, postprandial C-peptide excursion was significantly increased (DMR, 0.41 ng/mL; sham, 0.02 ng/mL; P = 0.012) and postprandial glucagon excursion was significantly decreased (DMR, -8.03 pg/mL; sham, 2.13 pg/mL; P = 0.027). Conclusion: DMR markedly improves glucose responses to a mixed meal challenge, primarily driven by a decrease in FPG, suggesting a primary effect on insulin resistance. Increases in C-peptide and reductions in glucagon levels suggest improvement in beta cell function in addition to improvements in hepatic insulin sensitivity, and ratifies the position of the duodenum as both a culprit endocrine organ and therapeutic target for patients with T2D.
机译：背景：十二指肠是代谢平衡的关键代谢信号中心和调节器。因此十二指肠粘膜增生是针对与胰岛素抵抗代谢性疾病的潜在治疗靶标。以前的报告表明，DMR，微创，内镜下黏膜切除过程中，安全地提高肝，血糖指标。从REVITA-2，第一随机，假对照，双盲，DMR安全性和有效性在T2D患者的前瞻性，多中心研究的主要终点，均达到和以前的报告。在这里，我们进一步探索从REVITA-2研究分析混合膳食耐受性测试（MMTT）数据底层DMR对肝和葡萄糖代谢的有益作用的机制。方法：符合条件的患者（HbA1c的7.5-10％，BMI≥24至≤为40kg / m 2时，与口服≥1抗糖尿病药物稳定的处理）接收的DMR或假步骤（1：1）。探索性终点包括在经2小时的曲线（AUC）下的空腹血糖（FPG），MMTT葡萄糖面积位数的变化，并且在2小时内于MMTT C肽和胰高血糖的变化，从基线到12周后-DMR。基于秩ANCOVA模型，而不会在0.05的显着性水平插补评估治疗差异片面的P值。修改后的意向性治疗主要分析人群包括随机患者在其中学习过程进行了尝试。结果：共70例（DMR，N = 35;假，N = 35）被包括在分析中，其中57％和54％（DMR中，n = 20;假，N = 19）的基线FPG≥ 180毫克/分升。中位数AUC MMTT葡萄糖与假相比被降低显著后DMR（-36.38毫克/分升）（-4.94 mg / dL的; P = 0.009），通过在FPG（DMR，-41.0毫克/ dL的减少显著驱动;假，-15.0毫克/分升; P = 0.003），而不是中值MMTT餐后葡萄糖偏移（DMR，-4.63 mg / dL的;假，5.34毫克/升; P = 0.209）。 AUC葡萄糖降低了更明显的患者基线FPG≥180与基线FPG <180（DMR，-26.81毫克/分升比较（DMR，-63.03毫克/分升;假，-20.31 mg / dL的P = 0.007）;假，13.81毫克/分升; P = 0.271）。患者基线FPG≥180，餐后C肽偏移被显著增加（DMR，0.41纳克/毫升;假，0.02毫微克/毫升; P = 0.012）和胰高血糖素餐后偏移被显著降低（DMR，-8.03皮克/毫升;假，2.13皮克/毫升; P = 0.027）。结论：DMR显着地改善到一个混合膳食葡萄糖挑战应答，主要是由在FPG的下降驱动，这表明对胰岛素抵抗的主要效果。在C-肽的增减在胰高血糖素水平的建议中，除了在肝胰岛素灵敏度的提高，批准十二指肠既作为罪魁祸首内分泌器官和治疗靶T2D患者的位置的β细胞功能的改善。

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