DiabetesNCT02278068
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
A study testing Metabolic Neuromodulation System (MNS) in people with Diabetes and Endocrine, Nutritional and Metabolic Diseases (E00-E89), run by Metavention at 6 sites in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Endocrine, Nutritional and Metabolic Diseases (E00-E89)
- What is being tested?
- Metabolic Neuromodulation System (MNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesNew Zealand
- Study dates
- Oct 2014to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosed type 1 diabetes mellitus
- History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy
- Estimated glomerular filtration rate (GFR) < 60mL/min/1.73m2
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
New Zealand6 sites
Auckland City Hospital
Auckland
Middlemore Hospital
Auckland
North Shore Hospital
Auckland
Christchurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Wellington Hospital
Wellington
About this study
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.
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.
Read the 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.
- Being tested
- Metabolic Neuromodulation System (MNS)
- Keywords
- Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic Neuromodulation System (MNS)Device
Also called Hepatic sympathetic denervation
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 group | Role | What they receive |
|---|---|---|
| Metabolic Neuromodulation System (MNS) | Experimental | Hepatic sympathetic denervation therapy to aid in glycemic control Receives: Device: Metabolic Neuromodulation System (MNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
Incidence of serious adverse device effects
Measured: 180 day follow-up
Secondary outcomes (4)
Device and Procedural success
Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure
Measured: 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
Measured: 180 day and 365 day follow-up
Laboratory Assessments/Cardiometabolic Changes
Assessment of chemistry/serum lab values to evaluate safety and performance
Measured: 180 day follow up
Adverse Event Rate
Summary of all reported adverse events during the study
Measured: 365 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metavention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Webster, Prof, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278068
- Sponsor's protocol ID
- MV-2014-ANZ-001
- Status last verified
- Mar 2020
- First submitted
- 23 Oct 2014
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02278068
- Acronym / sponsor ID
- MV-2014-ANZ-001
- Keywords
- Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- MetaventionIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic Neuromodulation System (MNS) | Experimental | Device: Metabolic Neuromodulation System (MNS)Hepatic sympathetic denervation therapy to aid in glycemic control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosed type 1 diabetes mellitus
- History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy
- Estimated glomerular filtration rate (GFR) < 60mL/min/1.73m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic Neuromodulation System (MNS)Also: Hepatic sympathetic denervationProspective, 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. | Device | Metabolic Neuromodulation System (MNS) |
Primary outcome
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
Time frame: 180 day follow-up
Incidence of serious adverse device effects
4 secondary outcomes
Device and Procedural success
Time frame: intra operative
Glycemic control
Time frame: 180 day and 365 day follow-up
Laboratory Assessments/Cardiometabolic Changes
Time frame: 180 day follow up
Adverse Event Rate
Time frame: 365 day follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Webster, Prof principal investigator
Auckland City Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic Neuromodulation System (MNS) in people with Diabetes and Endocrine, Nutritional and Metabolic Diseases (E00-E89), run by Metavention at 6 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Outcome as assessed by Incidence of serious adverse device effects (time frame: 180 day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.