Catheter-based endovascular celiac and hepatic denervation for type 2 diabetes: a multicenter, open-label, single-arm study

Abstract

Sympathetic hyperactivity is crucial driving factor for hyperglycemia in type 2 diabetes (T2D). We conducted a multicenter, open-label, single-arm trial to evaluate the safety and efficacy of endovascular denervation (EDN) targeting the celiac and hepatic arteries in patients with poorly controlled T2D, defined as glycated hemoglobin (HbA1c) > 7.5% and <10.5% despite treatment with metformin and at least one other antidiabetic agent (registered with the National Medical Products Administration of China and ClinicalTrials.gov, NCT05631561). A total of 37 patients were enrolled across three centers, and 30 patients underwent EDN between December 2022 and October 2023. Follow-up visits were conducted at 1, 3, 6, and 12 months. The primary endpoints were device- and/or procedure-related major adverse events (MAEs) within 30 days post-procedure and changes in HbA1c at 6 months. In treated patients, the baseline mean HbA1c was 9.0%, and the baseline mean fasting plasma glucose was 8.6 mmol/L. No MAEs were observed within 30 days. HbA1c decreased by 1.0% at 6 months (P < 0.001), with reductions of 1.0%, 1.2%, and 0.9% at 1, 3, and 12 months post-EDN, respectively. Time in range (3.9–10.0 mmol/L) increased by 15.4%, 14.9%, 7.6% and 11.7% at each follow-up time point. Blood pressure also showed reductions during follow-up. Adverse events were reported in 11 (37%) patients, with mild to moderate gastrointestinal symptoms being the most common. These exploratory findings provide a rationale for further evaluating the efficacy of EDN in improving glycemic control in T2D patients through randomized controlled trials.