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

March 24, 2020 updated by: Metavention

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
      • Auckland, New Zealand
        • Middlemore Hospital
      • Auckland, New Zealand
        • North Shore Hospital
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
      • Wellington, New Zealand
        • Wellington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metabolic Neuromodulation System (MNS)
Hepatic sympathetic denervation therapy to aid in glycemic control
Device: Metabolic 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.
Other Names:
  • Hepatic sympathetic denervation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and Procedural success
Time Frame: intra operative
Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure
intra operative
Glycemic control
Time Frame: 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
180 day and 365 day follow-up
Laboratory Assessments/Cardiometabolic Changes
Time Frame: 180 day follow up
Assessment of chemistry/serum lab values to evaluate safety and performance
180 day follow up
Adverse Event Rate
Time Frame: 365 day follow up
Summary of all reported adverse events during the study
365 day follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metavention

Investigators

  • Principal Investigator: Mark Webster, Prof, Auckland City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV-2014-ANZ-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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