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

Not Applicable

Completed

• Conditions: Diabetes; Endocrine, Nutritional and Metabolic Diseases (E00-E89)
• Interventions: Device: Metabolic Neuromodulation System (MNS)

• Registration Number: NCT02278068
• Lead Sponsor: Metavention

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-29
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metabolic Neuromodulation System (MNS)	Metabolic Neuromodulation System (MNS)	Hepatic sympathetic denervation therapy to aid in glycemic control

Primary Outcome Measures

Name	Time	Method
Primary Safety Outcome as assessed by Incidence of serious adverse device effects	180 day follow-up	Incidence of serious adverse device effects

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Dunedin Hospital; 🇳🇿 Dunedin, New Zealand

Middlemore Hospital; 🇳🇿 Auckland, New Zealand

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

North Shore Hospital; 🇳🇿 Auckland, New Zealand

Wellington Hospital; 🇳🇿 Wellington, New Zealand