Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
Trial Parameters
Brief Summary
This study is assess the safety and performance of the Neurotronic Infusion catheter for treatment of patients with Type 2 Diabetes (T2DM) and hypertension.
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for participation in the study: 1. Age ≥ 21 and ≤ 65 years at time of enrollment. 2. Disease diagnosed 2.1 Diagnosed with T2DM with baseline: 1. Fasting plasma glucose ≥ 140 mg/dl (7.8 mmol/l) and ≤ 270 mg/dL (15 mmol/L) 2. HbA1c levels ≥ 7.0% and ≤ 9.0% (53-75 mmol/mol) 3. Triglyceride level \< 400 mg/dL (4.52 mmol/L) 4. On oral anti-hyperglycemic drug regimen of metformin. Subjects may be on additional oral anti-hyperglycemic drug of a different drug class 5. Years of T2DM ≤ 10 years And / Or 2.2 Diagnosed hypertension with baseline: 1. Office blood pressure of SBP of ≥ 140 mmHg and ≤ 180 mmHg and DBP ≥ 90 mmHg 2. Mean 24-hour ambulatory SBP of ≥ 130 mmHg and ≤ 170 mmHg with ≥ 75% valid readings 3. On stable oral anti-hypertension drug regimen consisting of up to a maximum of three drugs 3. BMI between 27.5 and 40 kg/m2 4. C-peptide testing: non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pm