Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.
Department of Endocrinology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China; Institute of Pancreas, Southeast University, Nanjing, China.
J Vasc Interv Radiol. 2021 Nov;32(11):1519-1528.e2. doi: 10.1016/j.jvir.2021.07.023. Epub 2021 Aug 6.
To investigate the safety and efficacy of catheter-based endovascular denervation (EDN) at the celiac artery and abdominal aorta around the celiac artery on glycemic control in patients with type 2 diabetes mellitus (T2DM).
With a novel catheter system, EDN was conducted at the celiac artery along with the abdominal aorta around the celiac artery in patients with T2DM whose glycosylated hemoglobin (HbA1c) level was >7.5%. The primary outcome was HbA1c level at 6 months. Other outcomes included safety, oral glucose tolerance test, homeostasis model assessment of insulin resistance (HOMA-IR), fasting plasma glucose (FPG) level, 2-hour postprandial plasma glucose (2hPG) level, and C-peptide test.
A total of 11 subjects were included for analysis. The technical success was 100%, and no severe treatment-related adverse events or major complications were observed. Both HbA1c level and HOMA-IR were significantly reduced at 6 months (9.9% vs 8.0%, P = .005; 13.3 vs 6.0, P = .016). Decreases in FPG and 2hPG levels were observed (227.2 vs 181.8 mg/dL, P < .001; 322.2 vs 205.2 mg/dL, P = .001). The C-peptide test indicated improved β-cell function (area under the curve, 0.23 vs 0.28 pmol/mL, P = .046). A reduction of daily insulin injection (P = .02) and improvement of liver function (alanine aminotransferase, P = .014; γ-glutamyl transpeptidase, P = .021) were also observed.
EDN in the celiac artery and abdominal aorta around the celiac artery elicited a clinically significant improvement in glycemic control and insulin resistance in patients with T2DM, with good tolerability as demonstrated by 6-month follow-up.
研究经导管内脏去神经（EDN）治疗 2 型糖尿病（T2DM）患者腹腔动脉和腹腔动脉周围腹主动脉对血糖控制的安全性和有效性。
采用新型导管系统，对糖化血红蛋白（HbA1c）水平>7.5%的 T2DM 患者行腹腔动脉和腹腔动脉周围腹主动脉 EDN。主要结局为 6 个月时的 HbA1c 水平。其他结局包括安全性、口服葡萄糖耐量试验、稳态模型评估的胰岛素抵抗（HOMA-IR）、空腹血糖（FPG）水平、餐后 2 小时血糖（2hPG）水平和 C 肽试验。
共纳入 11 例患者进行分析。技术成功率为 100%，未观察到严重与治疗相关的不良事件或重大并发症。6 个月时，HbA1c 水平和 HOMA-IR 均显著降低（9.9%比 8.0%，P=0.005；13.3 比 6.0，P=0.016）。FPG 和 2hPG 水平下降（227.2 比 181.8 mg/dL，P<0.001；322.2 比 205.2 mg/dL，P=0.001）。C 肽试验表明β细胞功能改善（曲线下面积，0.23 比 0.28 pmol/mL，P=0.046）。每日胰岛素注射减少（P=0.02）和肝功能改善（丙氨酸氨基转移酶，P=0.014；γ-谷氨酰转肽酶，P=0.021）也观察到。
在 T2DM 患者的腹腔动脉和腹腔动脉周围腹主动脉进行 EDN 可显著改善血糖控制和胰岛素抵抗，6 个月随访显示耐受性良好。
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