What is the Neurotronic Infusion Catheter studying for Type 2 Diabetes and hypertension?

The Neurotronic Infusion Catheter is being studied to assess its safety and performance in treating adults with Type 2 Diabetes Mellitus and hypertension by chemically denervating renal and hepatic arteries. This research aims to understand if this approach can help manage these conditions. The study is sponsored by Neurotronic, Inc.

Who may be eligible for this Type 2 Diabetes and hypertension clinical trial?

Adults aged 21 to 65 years diagnosed with Type 2 Diabetes or hypertension may be eligible. Participants should have a BMI between 27.5 and 40 kg/m2 and be on specific medication regimens. Please review eligibility criteria for more details.

Is there any cost to participate in this Type 2 Diabetes and hypertension clinical trial?

Study-related care, including the study procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 21Years - 65Years

All Genders

ID05363761

Study of Neurotronic Infusion Catheter Ablation for Treating Type 2 Diabetes, Hypertension, and Obesity in Adults Aged 21 to 65

Led by Neurotronic, Inc. · Updated on 2023-03-21

Participants Needed

Research Sites

208 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and performance of the Neurotronic Infusion Catheter in treating adults with Type 2 Diabetes Mellitus T2DM and hypertension, conditions often accompanied by obesity. This prospective, single-arm, multi-center trial aims to study chemical denervation of renal and hepatic arteries to understand potential benefits for these patients. The study is sponsored by Neurotronic, Inc. and is conducted as a Phase 1 trial. Participants receive treatment using the Neurotronic Infusion Catheter, which delivers ethanol ablation to the renal and common hepatic arteries. This procedure aims to chemically denervate these arteries to address T2DM and hypertension. The trial involves a single treatment group undergoing this ablation procedure. During the study, participants will be closely monitored for safety and device performance starting immediately during the procedure and continuing for 30 days after. Follow-up assessments will evaluate glycemic and hypertension control at multiple time points, including 1, 3, 6, 12, and 24 months, with optional extended follow-ups up to 5 years. Researchers will collect data on serious device- and procedure-related complications, treatment success, and long-term health outcomes over the course of participation, which may extend up to several years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 65Years

All Genders

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 levels less than 400 mg/dL
On metformin and possibly additional oral anti-hyperglycemic drugs
Duration of Type 2 Diabetes less than or equal to 10 years
And/or diagnosed hypertension with office blood pressure systolic between 140 and 180 mmHg and diastolic 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 regimen 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 of 3 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 (HbA1c above 9.0% or use of insulin)
Diastolic blood pressure less than 90 mmHg
Use of more than three hypertension medications
Current use of beta blockers
Hospitalization for hyperglycemia episodes within 180 days prior to screening
History of serious hypoglycemia with loss of consciousness or confusion in 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 greater than 50%
Arterial abnormalities preventing safe catheter insertion
Occlusive peripheral vascular disease preventing femoral access
Known or suspected secondary hypertension causes
Regular use of NSAIDs two or more days per week in the prior month
Severe or unstable cardiovascular conditions
Renal or liver transplant history or severe kidney/liver disease
Recent or planned organ transplantation or surgery
Use of systemic corticosteroids, anticonvulsants, or sympatholytics within 90 days
Bleeding disorders or use of anticoagulants that cannot be stopped around procedure
Significant alcohol use or substance abuse
Significant recent weight loss
Hepatic decompensation or liver cirrhosis
Chronic liver or biliary diseases including hepatitis B or C
HIV infection
Adverse reaction to heparin
Systemic infections increasing procedural risk
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 study follow-up
Lack of informed consent
Concurrent medical conditions affecting safety or evaluation
Participation in other pre-market drug or device clinical studies

Research Team

Yunlong Zhang, MD

John Chen, PhD

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Study of Neurotronic Infusion Catheter Ablation for Treating Type 2 Diabetes, Hypertension, and Obesity in Adults Aged 21 to 65

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria