Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities

Recruiting now · Phase 1

Conditions studied: Diabetes Mellitus, Type 2, Hypertension

In brief

This study is assess the safety and performance of the Neurotronic Infusion catheter for treatment of patients with Type 2 Diabetes (T2DM) and hypertension.

Key facts

Study ID

NCT05363761

Run by

Neurotronic, Inc.

People needed

50

Starts

2022-04-19

Expected to finish

2029-01-01

Last updated by the study team

2023-03-21

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be eligible for participation in the study:
• Age ≥ 21 and ≤ 65 years at time of enrollment.
• Disease diagnosed
• 1 Diagnosed with T2DM with baseline:
• Fasting plasma glucose ≥ 140 mg/dl (7.8 mmol/l) and ≤ 270 mg/dL (15 mmol/L)
• HbA1c levels ≥ 7.0% and ≤ 9.0% (53-75 mmol/mol)
• Triglyceride level < 400 mg/dL (4.52 mmol/L)
• On oral anti-hyperglycemic drug regimen of metformin. Subjects may be on additional oral anti-hyperglycemic drug of a different drug class
• Years of T2DM ≤ 10 years
• And / Or
• 2 Diagnosed hypertension with baseline:
• Office blood pressure of SBP of ≥ 140 mmHg and ≤ 180 mmHg and DBP ≥ 90 mmHg
• Mean 24-hour ambulatory SBP of ≥ 130 mmHg and ≤ 170 mmHg with ≥ 75% valid readings
• On stable oral anti-hypertension drug regimen consisting of up to a maximum of three drugs
• BMI between 27.5 and 40 kg/m2
• C-peptide testing: non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/L)
• Vessel diameter of 3 mm to 7 mm with a minimum arterial treatable length of 20 mm in one or more of the following arteries:
• Renal
• Hepatic

You may not qualify if…

• T1DM or poorly controlled T2DM (defined as HbA1c > 9.0% or use insulin as medication to control glucose level).
• Office diastolic blood pressure < 90 mmHg.
• Current use of > 3 hypertension medications.
• Currently on beta blockers.
• One or more documented hyperglycemia episodes requiring hospitalization in the 180-day prior to screening date.
• Prior evidence of hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months.
• BMI > 40 kg/m2.
• Diagnosed proliferative retinopathy or evidence of peripheral neuropathy.
• Lack of appropriate treatment site or anatomy precluding the intervention of the target arteries (renal and hepatic artery).
• History of prior renal or hepatic artery intervention including balloon angioplasty, stenting, etc.
• Arterial stenosis >50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).
• Any abnormality or disease in one or more of the target arteries that, per the physician assessment, precludes the safe insertion of the guiding catheter (including, but not limited to, artery aneurysm, excessive tortuosity, calcification).
• Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure.
• Known or suspected secondary hypertension, such as Cushing's disease or Cushing's Syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, history of pre-eclampsia, onset of hypertension prior to the age of 18.
• Use of nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
• Severe or unstable cardiovascular comorbidities, such as AMI or ACS, cardiac valve stenosis, pulmonary embolism, heart failure with NYHA Class III or IV, chronic atrial fibrillation, primary pulmonary hypertension, COPD.
• Renal transplant, history of nephrectomy or single kidney, renal tumor/cancer, known non-functioning kidney, unequal renal size (>2 cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function), chronic renal deficiency with eGFR ≤ 60ml/min/1.73m2, or on chronic renal replacement therapy.
• Prior liver transplant.
• Any organ transplantation procedures are planned in the 365 days following Index Procedure.
• Gastrointestinal permanent anatomic alteration surgery.
• Any surgical procedure within 30 days prior to Index Procedure.
• Currently taking the following medications within 90 days prior to screening and/or there is a need or anticipated need for these medications during the study:
• Systemic Corticosteroids
• Anticonvulsants
• Centrally acting sympatholytics

Where it is running

• Hospital Paitilla Clinicas y Hospitales — Panama City, Panama (enrolling)
• Hospital Punta Pacifica — Panama City, Panama (enrolling)
• Sanatorio Adventista de Asunción — Asunción, Paraguay (enrolling)

Full record on ClinicalTrials.gov

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