Multi-electrode endovascular denervation at a new site of celiac artery for glycemic control in patients with type 2 diabetes mellitus: a promisingly primary result
Abstract Background: Although renal denervation (RDN) may theoretically be effective on type 2 diabetes mellitus (T2DM), most clinical data failed to demonstrate such a concept. We investigated the safety and primary effects of catheter-based endovascular denervation (EDN) at new sites of the celiac artery (CA), and the abdominal aorta around CA using a novel multi-electrode device on glycemic control in T2DM patients. Methods: With a novel six-electrode catheter system, EDN was conducted in T2DM patients at new sites of CA and aorta between CA and superior mesenteric artery (SMA) in purpose of targeting on the postganglionic efferent nerves innervating the liver, islet, and other metabolic organs. The major inclusion criteria were T2DM patients diagnosed over 5 years, with hemoglobin A1c (HbA1c) over 7.5%. The primary outcomes were evaluated by the safety, HbA1c, homeostasis-model assessment of insulin resistance (HOMA-IR), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPG), and oral glucose tolerance test (OGTT) based 3-hour C-peptide test. The antidiabetic medication, lifestyle, physical condition, blood pressure (BP), plasma norepinephrine, angiotensin II, liver biochemistry, and plasma lipids were also recorded.Results: A total of 11 patients were included for analysis. The technical success was 100% and no severe treatment-related adverse events or major complications were observed. Both HbA1c and HOMA-IR significantly reduced at 6 months (9.9 vs. 8.0, P = 0.005; 13.3 vs. 6.0, P = 0.016, respectively). Decreases of FPG and 2hPG were observed (15.4 vs.10.1 mmol/L, P < 0.001; 17.9 vs. 11.4 mmol/L, P = 0.001, respectively). OGTT based C-peptide test indicated improved beta-cell function ([AUC] 0.23 vs. 0.28 pmol/mL, P =0.046). A reduction of daily insulin injection (P = 0.02) and improvement of liver function (ALT, P = 0.014; GGT, P = 0.021) were also observed without changes in lifestyle, physical conditions, and other metabolic measurements.Conclusions: The 6-month analysis of this trial showed that EDN at new sites of CA and the abdominal aorta around celiac artery using the novel six-electrode catheter system elicits a clinically significant improvement in glycemic control and insulin resistance in patients with T2DM, with good tolerability. Trial Registration Number NCT 04086043, dated 11/9/2019.