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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
a sterile, single use catheter (device) for delivering chemical agent to achieve perivascular denervation.
Sanatorio Italiano - Centro de Intervenciones Endovasculares
Asunción, Paraguay
Incidence of Serious Device- and Procedure-Related Complications
This composite endpoint is defined as: * death * flow-limiting dissection of the treated one or more of the arteries requiring intervention * perforation of the treated artery requiring intervention * bleeding requiring transfusion due to severe leakage at treatment site * severe or occlusive thrombosis of the treated artery beds * distal embolization of the treated artery beds
Time frame: at 30 Days post procedure
Glycemic Control (1)
Improvement of HbA1c (%) will be analyzed by absolute and relative changes. Percent subjects with decrease HbA1c will also be analyzed.
Time frame: at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.
Glycemic Control (2)
Improvement of fasting glucose (mg/dl) will be analyzed by absolute and relative changes. Percent subjects with decrease fasting glucose will also be analyzed.
Time frame: at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.
Hypertension Control
Improvement of blood pressure (mmHg) will be analyzed by absolute and relative changes.
Time frame: at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.
Weight Control (1)
The improvement of the body weight (weight in kg) will be analyzed by absolute and relative changes.
Time frame: at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.
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Weight Control (2)
The improvement of the body weight will be analyzed by Body Mass Index (BMI in kg/m\^2) absolute and relative changes.
Time frame: at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.
Device Success
Device success, defined as successful introduction of the catheter, navigation to the treatment site, deployment of the features, and infusion of the chemical agent to the intended area without device malfunction that requiring abort the procedure.
Time frame: during procedure or immediately after procedure
Procedure Success
Procedure success, defined as device success without any serious device- and procedure-related complications during the procedure and prior to hospital discharge.
Time frame: during procedure or immediately after procedure