COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diabetes, Endocrine, Nutritional and Metabolic Diseases (E00-E89)

Intervention / Treatment
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* Device: Metabolic Neuromodulation System (MNS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metabolic Neuromodulation System (MNS)<br>Hepatic sympathetic denervation therapy to aid in glycemic control | Device: Metabolic Neuromodulation System (MNS)<br>* 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.<br>* Other names: Hepatic sympathetic denervation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Outcome as assessed by Incidence of serious adverse device effects | Incidence of serious adverse device effects | 180 day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device and Procedural success | Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure | intra operative | 
| Glycemic control | Number of subjects with a decrease in HbA1c, change in plasma glucose based on fasting glucose and oral glucose tolerance test | 180 day and 365 day follow-up | 
| Laboratory Assessments/Cardiometabolic Changes | Assessment of chemistry/serum lab values to evaluate safety and performance | 180 day follow up | 
| Adverse Event Rate | Summary of all reported adverse events during the study | 365 day follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes