Diabetes, Endocrine, Nutritional and Metabolic Diseases (E00-E89)
Conditions
Keywords
Type 2 diabetes
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.
Interventions
DEVICEMetabolic Neuromodulation System (MNS)
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.
Sponsors
Metavention
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Outcome as assessed by Incidence of serious adverse device effects | 180 day follow-up | Incidence of serious adverse device effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device and Procedural success | intra operative | Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure |
| Glycemic control | 180 day and 365 day follow-up | Number of subjects with a decrease in HbA1c, change in plasma glucose based on fasting glucose and oral glucose tolerance test |
| Laboratory Assessments/Cardiometabolic Changes | 180 day follow up | Assessment of chemistry/serum lab values to evaluate safety and performance |
| Adverse Event Rate | 365 day follow up | Summary of all reported adverse events during the study |
Countries
New Zealand
Outcome results
None listed