A First in Human (FIH) Clinical Study to Assess Safety and Performance of Hepatic Sympathetic Denervation for Treatment of Inadequately Controlled Type 2 Diabetic Subjects on Oral Antihyperglycemic Agents.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Metavention
- Enrollment
- 46
- Locations
- 6
- Primary Endpoint
- Primary Safety Outcome as assessed by Incidence of serious adverse device effects
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this research study is to collect information about a new treatment for Type 2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well controlled despite treatment with multiple medications. The medical device delivers low-level radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves that lead to the liver. Previous research has shown that disrupting these nerves may lead to a lowering of blood sugar levels.
Detailed Description
Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-65 years
- •Uncontrolled T2DM, as evidenced by HbA1c levels, on a consistent oral anti-hyperglycemic drug regimen of at least two different drug classes
- •Documented status of stable lifestyle modifications
Exclusion Criteria
- •Diagnosed type 1 diabetes mellitus
- •History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy
- •Estimated glomerular filtration rate (GFR) \< 60mL/min/1.73m2
Outcomes
Primary Outcomes
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
Time Frame: 180 day follow-up
Incidence of serious adverse device effects
Secondary Outcomes
- Device and Procedural success(intra operative)
- Glycemic control(180 day and 365 day follow-up)
- Laboratory Assessments/Cardiometabolic Changes(180 day follow up)
- Adverse Event Rate(365 day follow up)