Actively Recruiting
Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
Led by Neurotronic, Inc. · Updated on 2023-03-21
50
Participants Needed
3
Research Sites
349 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 assess the safety and performance of the Neurotronic Infusion catheter for treatment of patients with Type 2 Diabetes (T2DM) and hypertension.
CONDITIONS
Official Title
Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 65 years at enrollment
- Diagnosed with Type 2 Diabetes Mellitus with fasting plasma glucose 140-270 mg/dL and HbA1c 7.0%-9.0%
- Triglyceride level below 400 mg/dL
- On metformin and possibly other oral anti-hyperglycemic drugs
- Duration of Type 2 Diabetes Mellitus 10 years or less
- And/or diagnosed hypertension with office systolic blood pressure 140-180 mmHg and diastolic blood pressure 90 mmHg or higher
- Mean 24-hour ambulatory systolic blood pressure 130-170 mmHg with at least 75% valid readings
- On stable oral anti-hypertension regimen of up to three drugs
- Body mass index (BMI) between 27.5 and 40 kg/m2
- Non-fasting random or stimulated C-peptide of 2 ng/mL or higher
- Vessel diameter 3 mm to 7 mm with minimum arterial treatable length of 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 over 9.0% or insulin use)
- Diastolic blood pressure below 90 mmHg
- Use of more than three hypertension medications
- Current use of beta blockers
- Hospitalization for hyperglycemia in the past 180 days
- History of serious hypoglycemia with loss of consciousness or confusion in last 6 months
- Body mass index (BMI) above 40 kg/m2
- Diagnosed proliferative retinopathy or peripheral neuropathy
- Unsuitable anatomy or treatment site in renal or hepatic arteries
- Previous renal or hepatic artery interventions
- Arterial stenosis over 50% in target arteries
- Artery abnormalities preventing safe catheter insertion
- Peripheral vascular disease preventing femoral access
- Known or suspected secondary hypertension conditions
- Use of NSAIDs two or more days per week in the last month
- Severe or unstable cardiovascular diseases
- Renal transplant, nephrectomy, single kidney, kidney tumors, or chronic kidney disease with eGFR 60 ml/min/1.73m2 or less
- Prior liver transplant or planned organ transplant within 365 days
- Gastrointestinal permanent anatomic alteration surgery
- Recent surgery within 30 days prior to procedure
- Use of systemic corticosteroids, anticonvulsants, or centrally acting sympatholytics within 90 days prior to screening
- Bleeding disorders or anticoagulation therapy that cannot be stopped
- Other conditions compromising safety or study quality
- Significant alcohol consumption or active substance abuse within 1 year
- Significant recent weight loss over 10%
- Hepatic decompensation or liver diseases including hepatitis, liver cancer, cirrhosis, or related conditions
- History of acute or chronic 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 under 5 years
- Inability or unwillingness to comply with follow-up
- Inability to provide informed consent
- Concurrent medical conditions affecting safety or evaluation
- Participation in another pre-market drug or device trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hospital Paitilla Clinicas y Hospitales
Panama City, Panama, 0816-03075
Actively Recruiting
2
Hospital Punta Pacifica
Panama City, Panama
Actively Recruiting
3
Sanatorio Adventista de Asunción
Asunción, Paraguay
Actively Recruiting
Research Team
Y
Yunlong Zhang, MD
CONTACT
J
John Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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