Type 2 Diabetes Mellitus With Circulatory Complciation Clinical Trial
Official title:
Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
The study is to assess the safety and feasibility of chemical denervation of multiple artery beds for the treatment of Type 2 diabetes (T2DM) and its comorbidities.
Diabetes mellitus is among the most prevalent chronic diseases, affecting 435 million persons as of 2015 with an annual death toll of 1.5 million, and the overwhelming majority of these have Type 2 diabetes mellitus (T2DM). Hypertension is a common comorbidity of diabetes and present in more than 50% of diabetic patients. The risk for cardiovascular disease (CVD) is four-fold higher in patients with both DM and hypertension as compared to the normotensive non-diabetic controls. Obesity, with a prevalence of over 500 million, is another common comorbidity of diabetes. These are chronic diseases associated with increased risks of cardiovascular disease, stroke, and decreased quality of life. Neurotronic developed a novel catheter for denervation procedure. Chemical agent is delivered locally into the adventitial space and ablates the sympathetic nerve and nerve endings in the adventitial space of the target arteries. The purpose of the study is to assess the safety and feasibility of chemical denervation of the target arteries for the treatment of Type 2 diabetes (T2DM) and its comorbidities. ;
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