Back to resultsCOMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
Primary Purpose
Diabetes, Endocrine, Nutritional and Metabolic Diseases (E00-E89)
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Metabolic Neuromodulation System (MNS)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Type 2 diabetes
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
Sites / Locations
- Auckland City Hospital
- Middlemore Hospital
- North Shore Hospital
- Christchurch Hospital
- Dunedin Hospital
- Wellington Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metabolic Neuromodulation System (MNS)
Arm Description
Hepatic sympathetic denervation therapy to aid in glycemic control
Outcomes
Primary Outcome Measures
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
Incidence of serious adverse device effects
Secondary Outcome Measures
Device and Procedural success
Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure
Glycemic control
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
Assessment of chemistry/serum lab values to evaluate safety and performance
Adverse Event Rate
Summary of all reported adverse events during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02278068
Brief Title
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metavention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Endocrine, Nutritional and Metabolic Diseases (E00-E89)
Keywords
Type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metabolic Neuromodulation System (MNS)
Arm Type
Experimental
Arm Description
Hepatic sympathetic denervation therapy to aid in glycemic control
Intervention Type
Device
Intervention Name(s)
Metabolic Neuromodulation System (MNS)
Other Intervention Name(s)
Hepatic sympathetic denervation
Intervention 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.
Primary Outcome Measure Information:
Title
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
Description
Incidence of serious adverse device effects
Time Frame
180 day follow-up
Secondary Outcome Measure Information:
Title
Device and Procedural success
Description
Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure
Time Frame
intra operative
Title
Glycemic control
Description
Number of subjects with a decrease in HbA1c, change in plasma glucose based on fasting glucose and oral glucose tolerance test
Time Frame
180 day and 365 day follow-up
Title
Laboratory Assessments/Cardiometabolic Changes
Description
Assessment of chemistry/serum lab values to evaluate safety and performance
Time Frame
180 day follow up
Title
Adverse Event Rate
Description
Summary of all reported adverse events during the study
Time Frame
365 day follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Webster, Prof
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Facility Name
North Shore Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
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