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

NCT05369065 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: PR 2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

This study is to assess the safety and performance of the Neurotronic Infusion Catheter and ethanol denervation of renal and hepatic arteries for the treatment of patients with Type 2 Diabetes (T2DM), Hypertension and Obesity.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Keywords

Diabetes; Hypertension; Ablation; Denervation

Outcome Measures

Primary Outcomes (2)

• Incidence of serious device- and procedure-related complications at 30 days post procedure.

  This composite endpoint is defined as: * death * flow-limiting dissection at one or more of the treated arteries requiring intervention. * Type III perforation of the treated artery requiring intervention. * bleeding requiring transfusion. * severe or occlusive thrombosis of the treated artery beds * clinically significant distal embolization of the treated artery beds * clinically significant damage to kidneys and/or liver

  30 Days

• Device success

  The device success, defined as successful introduction of the catheter, navigation to the treatment site, and infusion of the chemical to the intended area without device malfunction requiring aborting the procedure.

  Procedure Day

Secondary Outcomes (7)

• Glycemic Control - HbA1c

  Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years

• Glycemic Control - fasting glucose

  Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years

• Hypertension Control - ABPM

  Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years

• Hypertension Control - Office Blood Pressure

  Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years

• Procedure success

  Procedure Day

Study Arms (3)

Ablation Treatment

EXPERIMENTAL

The participants randomized to this arm will receive Neurotronic ablation treatment.

Combination Product: Ablation Treatment

Sham Treatment

SHAM COMPARATOR

The participants randomized to this arm will have a sham procedure (angiography only)

Diagnostic Test: Arterial Angiography Only

Single Arm non-Randomized Treatment

EXPERIMENTAL

The participants treated in this arm will receive the Neurotronic ablation treatment

Combination Product: Single Arm non-Randomized Ablation Treatment

Interventions

Ablation Treatment COMBINATION_PRODUCT

Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter

Ablation Treatment

Arterial Angiography Only DIAGNOSTIC_TEST

Arterial Angiography Only without Intervention

Sham Treatment

Single Arm non-Randomized Ablation Treatment COMBINATION_PRODUCT

Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter

Single Arm non-Randomized Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 and ≤ 65 years at time of enrollment.
• 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
• 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 6.5 mm inclusively with a minimum arterial treatable length of 20 mm in one or more of the following arteries:
• Renal

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 or alpha 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.

Sponsors & Collaborators

• Neurotronic, Inc.: lead
• Libra Medical: collaborator

Study Sites (3)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

RECRUITING

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

RECRUITING

Tbilisi Heart Center

Tbilisi, 0186, Georgia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John Chen, PhD

  Neurotronic, Inc.

  STUDY DIRECTOR

Central Study Contacts

Yunlong Zhang, MD

CONTACT

+1 669-203-9308; pzhang@libramed.com

John Chen, PhD

CONTACT

+1 763-273-6100; chenj@neurotronic.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and follow-up investigators in the randomized cohort will be blinded to the intervention. Subjects in the single-arm treatment non-randomized cohort are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter safety and performance study including two groups: a double-blind, randomized, sham controlled cohort and a single-arm treatment non-randomized cohort.

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 11, 2022
• Study Start: January 27, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

GE (3)