Diabetes Mellitus, Type 2Phase 1NECTAR IVNCT05369065
Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
A Phase 1 study testing Ablation Treatment, Arterial Angiography Only and Single Arm non-Randomized Ablation Treatment in people with Diabetes Mellitus, Type 2 and Hypertension, run by Neurotronic, Inc. at 3 sites in Georgia.
Trial 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. 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?
- Ablation Treatment, Arterial Angiography Only and Single Arm non-Randomized Ablation Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesGeorgia
- Study dates
- 27 Jan 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
- 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
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- 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
- 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 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.
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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.
- Lacking capacity 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 1 country. Contact the study team or a site near you to ask about taking part.
Georgia3 sites, 3 recruiting
- Recruiting
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
Irakli Goroshvili, MD
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
George Khabeishvili, MD
- Recruiting
Tbilisi Heart Center
Tbilisi, 0186
Archil Chukhrukidze, MD
About this study
Official title: Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities (NECTAR IV Trial)
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Ablation Treatment, Arterial Angiography Only, Single Arm non-Randomized Ablation Treatment
- 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.
Ablation TreatmentCombination product
Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter
Arterial Angiography OnlyDiagnostic test
Arterial Angiography Only without Intervention
Single Arm non-Randomized Ablation TreatmentCombination product
Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter
| Study group | Role | What they receive |
|---|---|---|
| Ablation Treatment | Experimental | The participants randomized to this arm will receive Neurotronic ablation treatment. Receives: Combination Product: Ablation Treatment |
| Sham Treatment | Sham comparator | The participants randomized to this arm will have a sham procedure (angiography only) Receives: Diagnostic Test: Arterial Angiography Only |
| Single Arm non-Randomized Treatment | Experimental | The participants treated in this arm will receive the Neurotronic ablation treatment Receives: Combination Product: Single Arm non-Randomized Ablation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Procedure Day
Secondary outcomes (7)
Glycemic Control - HbA1c
Change in HbA1c will be analyzed by absolute and relative changes. Percent subjects with decreased HbA1c will also be analyzed.
Measured: 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
Change in fasting glucose will be analyzed by absolute and relative changes. Percent subjects with decreased fasting glucose will also be analyzed.
Measured: 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
Change in ABPM will be analyzed by systolic, diastolic, and mean arterial pressure, absolute and relative changes of ABPM blood pressure. Percent subjects with decrease blood pressure will also be analyzed.
Measured: 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
Change in office blood pressure will be analyzed by systolic, diastolic, and mean arterial pressure, absolute and relative changes of office blood pressure. Percent subjects with decrease blood pressure will also be analyzed.
Measured: Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years
Procedure success
The procedure success, defined as successfully completion of at least one vessel treatment with Neurotronic Infusion Catheter without any serious device- and procedure-related complications during the procedure and prior to hospital discharge
Measured: Procedure Day
Change of anti-hyperglycemic medications
The change of anti-hyperglycemic medications will be analyzed by numbers of medications and dose changes of medications.
Measured: Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years
Change of anti-hypertensive medications
The change of anti-hypertensive medications will be analyzed by numbers of medications and dose changes of medications.
Measured: Discharge up to 5 Days, 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.
- First posted11 May 2022
- Study start27 Jan 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurotronic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Responsible party
- Sponsor
- Investigators
- John Chen, PhD, Study director, Neurotronic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369065
- Sponsor's protocol ID
- PR 2013
- Acronym
- NECTAR IV
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities (NECTAR IV Trial)
- ClinicalTrials.gov ID
- NCT05369065
- Acronym / sponsor ID
- NECTAR IV / PR 2013
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- Diabetes, Hypertension, Ablation, Denervation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Neurotronic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Ablation Treatment | Experimental | Combination Product: Ablation TreatmentThe participants randomized to this arm will receive Neurotronic ablation treatment. |
| Sham Treatment | Sham comparator | Diagnostic Test: Arterial Angiography OnlyThe participants randomized to this arm will have a sham procedure (angiography only) |
| Single Arm non-Randomized Treatment | Experimental | Combination Product: Single Arm non-Randomized Ablation TreatmentThe participants treated in this arm will receive the Neurotronic ablation treatment |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 21 and ≤ 65 years at time of enrollment.
- Diagnosed with T2DM with baseline:
- Diagnosed hypertension with baseline:
- BMI between 27.5 and 40 kg/m2
- C-peptide testing: non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/L)
Key exclusion criteria (62 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation TreatmentDenervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter | Combination product | Ablation Treatment |
| Arterial Angiography OnlyArterial Angiography Only without Intervention | Diagnostic test | Sham Treatment |
| Single Arm non-Randomized Ablation TreatmentDenervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter | Combination product | Single Arm non-Randomized Treatment |
Primary outcome
Incidence of serious device- and procedure-related complications at 30 days post procedure.
Time frame: 30 Days
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
Device success
Time frame: Procedure Day
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.
7 secondary outcomes
Glycemic Control - HbA1c
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years
Procedure success
Time frame: Procedure Day
Change of anti-hyperglycemic medications
Time frame: Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years
Change of anti-hypertensive medications
Time frame: Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Chen, PhD study director
Neurotronic, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ablation Treatment, Arterial Angiography Only and Single Arm non-Randomized Ablation Treatment in people with Diabetes Mellitus, Type 2 and Hypertension, run by Neurotronic, Inc. at 3 sites in Georgia.
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 16 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 22 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 Georgia. 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. Some participants in this study may receive a placebo. 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?
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 22 Mar 2023.