Actively Recruiting
Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
Led by Neurotronic, Inc. · Updated on 2023-03-22
60
Participants Needed
3
Research Sites
361 weeks
Total Duration
On this page
Sponsors
N
Neurotronic, Inc.
Lead Sponsor
L
Libra Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 65 years at enrollment
- Diagnosed with Type 2 Diabetes Mellitus with fasting plasma glucose between 140 and 270 mg/dL
- HbA1c levels between 7.0% and 9.0%
- Triglyceride level below 400 mg/dL
- On metformin treatment, possibly with additional oral anti-hyperglycemic drugs
- Duration of Type 2 Diabetes Mellitus less than or equal to 10 years
- Diagnosed hypertension with office systolic blood pressure between 140 and 180 mmHg and diastolic blood pressure at least 90 mmHg
- Mean 24-hour ambulatory systolic blood pressure between 130 and 170 mmHg with at least 75% valid readings
- On stable oral anti-hypertension treatment of up to three drugs
- Body mass index between 27.5 and 40 kg/m2
- C-peptide level of at least 2 ng/mL
- Vessel diameter from 3 mm to 6.5 mm and treatable arterial length of at least 20 mm in renal or hepatic arteries
You will not qualify if you...
- Type 1 Diabetes Mellitus or poorly controlled Type 2 Diabetes Mellitus (HbA1c above 9.0% or insulin use)
- Office diastolic blood pressure below 90 mmHg
- Currently using more than three hypertension medications
- Currently on beta blockers or alpha blockers
- Hospitalization for hyperglycemia episodes in the past 180 days
- History of serious hypoglycemia with loss of consciousness or confusion in the last 6 months
- Body mass index above 40 kg/m2
- Diagnosed proliferative retinopathy or peripheral neuropathy
- Unsuitable anatomy for intervention in renal or hepatic arteries
- Prior renal or hepatic artery interventions
- Arterial stenosis above 50% in target arteries
- Artery abnormalities preventing safe catheter use
- Peripheral vascular disease preventing femoral access
- Known or suspected secondary hypertension
- Frequent use of NSAIDs in the month before enrollment
- Severe or unstable cardiovascular conditions
- Significant kidney or liver diseases or transplant history
- Planned organ transplantation within 365 days after procedure
- Recent major surgery within 30 days prior to procedure
- Use of systemic corticosteroids, anticonvulsants, or centrally acting sympatholytics within 90 days before screening
- Bleeding disorders or inability to stop anticoagulation therapy around procedure
- Other conditions compromising safety or study quality
- Significant alcohol or substance abuse
- Significant recent weight loss
- Liver enzyme abnormalities or liver cirrhosis
- Chronic liver or biliary diseases including hepatitis or liver cancer
- History of pancreatitis
- HIV infection
- History of adverse reaction to heparin
- Systemic infection posing procedural risk
- Known allergies to contrast media, nickel, or ethanol
- Depression or use of antidepressants
- Pregnancy, breastfeeding, or planning pregnancy within 12 months
- Life expectancy less than 5 years
- Inability or unwillingness to comply with study follow-up
- Lack of capacity to consent
- Concurrent medical conditions affecting evaluation or safety
- Participation in another pre-market drug or device study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia, 0112
Actively Recruiting
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, 0159
Actively Recruiting
3
Tbilisi Heart Center
Tbilisi, Georgia, 0186
Actively Recruiting
Research Team
Y
Yunlong Zhang, MD
CONTACT
J
John Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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