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Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities (NECTAR IV Trial)

NCT05369065•Neurotronic, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

Prospective, multicenter safety and performance study including two groups: a double-blind, randomized, sham controlled cohort and a single-arm treatment non-randomized cohort. Eligible subjects in the randomized cohort will be randomized in a 2:1 ratio to the ablation treatment group or to the sham treatment (control) group. Eligible subjects in the non-randomized cohort will all receive the ablation treatment. Randomized subjects and the follow-up investigators/study coordinators will be blinded to the treatment scheme for at least 6 months. The non-randomized cohort will not be blinded. Subjects in the randomized cohort that are assigned to sham (control) will be allowed to cross over to the treatment group if desired after 6 to 12 months if they continue to meet the inclusion criteria.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 21 and ≤ 65 years at time of enrollment.
•2. 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
•3. 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
+6 more criteria

Exclusion Criteria

•1. T1DM or poorly controlled T2DM (defined as HbA1c \> 9.0% or use insulin as medication to control glucose level).
•2. Office diastolic blood pressure \< 90 mmHg.
•3. Current use of \> 3 hypertension medications.
•4. Currently on beta blockers or alpha blockers.
•5. One or more documented hyperglycemia episodes requiring hospitalization in the 180-day prior to screening date.
•6. Prior evidence of hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months.
•7. BMI \> 40 kg/m2.
•8. Diagnosed proliferative retinopathy or evidence of peripheral neuropathy.
•9. Lack of appropriate treatment site or anatomy precluding the intervention of the target arteries (renal and hepatic artery).
•10. History of prior renal or hepatic artery intervention including balloon angioplasty, stenting, etc.
+52 more criteria

Locations (3)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Tbilisi Heart Center

Tbilisi, Georgia

Key Dates

Start Date

January 27, 2022

Primary Completion Date

January 1, 2025

Completion Date

January 1, 2029

Last Updated

March 22, 2023

Enrollment

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 2Hypertension

Interventions

Ablation Treatment

COMBINATION_PRODUCT

Arterial Angiography Only

DIAGNOSTIC_TEST

Single Arm non-Randomized Ablation Treatment

COMBINATION_PRODUCT

Contacts

Yunlong Zhang, MD

CONTACT

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

John Chen, PhD

CONTACT

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

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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