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Diabetes Mellitus, Type 2Phase 1NECTAR IIINCT05363761

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

A Phase 1 study testing Neurotronic Infusion Catheter in people with Diabetes Mellitus, Type 2 and Hypertension, run by Neurotronic, Inc. at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2, Hypertension
What is being tested?
Neurotronic Infusion Catheter
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesin 2 countries
Study dates
19 Apr 2022to Jan 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 2.1 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)
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  • 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
  • 2.2 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

Who cannot join

  • 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.
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  • 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
  • Bleeding disorders, such as bleeding diathesis, thrombocytopenia, and severe anemia.
  • Use of anticoagulation therapy which cannot be discontinued from 7 days before or 14 days after the Index Procedure.
  • Any other condition(s) that would compromise the safety of the Subject or compromise study quality as judged by the investigator.
  • Significant alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to reliably quantify alcohol intake.
  • Active substance abuse, based on Investigator judgement, including inhaled or injected drugs, within 1 year prior to the initial screening.
  • Significant weight loss within the last 6 months (e.g., > 10% total body weight loss).
  • Hepatic decompensation defined as the presence of any of the following:
  • Serum albumin less than 3.5 g/dL
  • International normalization ratio (INR) greater than 1.4 (unless due to therapeutic anticoagulants)
  • Total bilirubin greater than 2 mg/dL with the exception of Gilbert syndrome
  • History of esophageal varices, ascites, or hepatic encephalopathy
  • ALT or AST greater than 200 U/L.
  • Diagnosis of liver cirrhosis.
  • Chronic liver or biliary disease of the following etiology:
  • History or diagnosis of Hepatitis B
  • History or diagnosis of Hepatitis C
  • History or diagnosis of current active autoimmune hepatitis
  • History or diagnosis of primary biliary cholangitis
  • History or diagnosis of primary sclerosing cholangitis
  • History or diagnosis of Wilson's disease
  • History or diagnosis of alpha-1-antitrypsin deficiency
  • History or diagnosis of hemochromatosis
  • History or diagnosis of drug-induced liver disease, as defined on the basis of typical exposure and history.
  • Known bile duct obstruction.
  • Suspected or proven liver cancer
  • History of acute or chronic pancreatitis.
  • Human immunodeficiency virus (HIV).
  • Subjects with a history of adverse reaction to heparin or heparin induced thrombocytopenia (HIT).
  • Systemic infection that the investigator judges would pose unacceptable procedural risks to the subject.
  • Known hypersensitivity to contrast media, nickel and ethanol that cannot be adequately pre-medicated.
  • Subject is depressed or on antidepressants.
  • Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
  • Life expectancy of less than 5 years.
  • Unwilling or unable to comply with the follow-up study requirements.
  • Subjects or their legally authorized representatives unable to provide informed consent.
  • Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
  • Currently participation in another pre-market drug or medical device clinical study.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Yunlong Zhang, MD contact

+1 669-203-9308

pzhang@libramed.com

John Chen, PhD contact

+1 763-273-6100

chenj@neurotronic.com

3 sites in 2 countries

Panama2 sites, 2 recruiting

  • Hospital Paitilla Clinicas y Hospitales

    Panama City, 0816-03075

    Guadalupe Perez, MD

    Recruiting

  • Hospital Punta Pacifica

    Panama City

    Guadalupe Pérez

    Recruiting

Other trials in Panama

Paraguay1 site, 1 recruiting

  • Sanatorio Adventista de Asunción

    Asunción

    Rubén G Servían Campos, MD

    Oscar L Paredes Gonzalez, MD, PhD

    Recruiting

Other trials in Paraguay

About this study

Official title: Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities (NECTAR III Trial)

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

Read the detailed description

This study is a prospective, single-arm, multi-center trial to evaluate the safety and performance of use of the Neurotronic Infusion Catheter for chemical denervation of renal and hepatic arteries for treatment of patients with type 2 diabetes, hypertension, and obesity.

Being tested
Neurotronic Infusion Catheter
Keywords
Diabetes, Hypertension, Ablation, Denervation
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurotronic Infusion CatheterCombination product

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

Study groups in NCT05363761
Study groupRoleWhat they receive
Ablation TreatmentExperimentalNeurotronic Infusion Catheter Treatment
Receives: Combination Product: Neurotronic Infusion Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 Days

  2. Device success

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

    Measured: During the procedure

Secondary outcomes (2)

  1. Glycemic Control:

    Change of fasting glucose and HbA1c will be analyzed by absolute and relative changes. Percent subjects with decreased fasting glucose and HbA1c will also be analyzed.

    Measured: 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years to understand the long-term effects of the treatment.

  2. Hypertension Control:

    Change of blood pressure will be analyzed by systolic, diastolic, and mean arterial pressure, absolute and relative changes of ABPM and office blood pressure. Percent subjects with decrease blood pressure will also be analyzed.

    Measured: 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start19 Apr 2022
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, up to 5 centers, non-randomized open label safety and performance study.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363761
Sponsor's protocol ID
PR 2012
Acronym
NECTAR III
Status last verified
Mar 2023
First submitted
2 May 2022
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neurotronic Infusion Catheter in people with Diabetes Mellitus, Type 2 and Hypertension, run by Neurotronic, Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 62 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Panama, Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yunlong Zhang, MD (+1 669-203-9308, pzhang@libramed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of serious device- and procedure-related complications at 30 days post procedure. (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05363761.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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