COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
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.
1 other identifier
interventional
46
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Oct 2014
Longer than P75 for not_applicable diabetes
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 26, 2020
March 1, 2020
4.6 years
October 23, 2014
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
Incidence of serious adverse device effects
180 day follow-up
Secondary Outcomes (4)
Device and Procedural success
intra operative
Glycemic control
180 day and 365 day follow-up
Laboratory Assessments/Cardiometabolic Changes
180 day follow up
Adverse Event Rate
365 day follow up
Study Arms (1)
Metabolic Neuromodulation System (MNS)
EXPERIMENTALHepatic sympathetic denervation therapy to aid in glycemic control
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosed type 1 diabetes mellitus
- History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy
- Estimated glomerular filtration rate (GFR) \< 60mL/min/1.73m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Metaventionlead
Study Sites (6)
Auckland City Hospital
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Wellington Hospital
Wellington, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Webster, Prof
Auckland City Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2014
First Posted
October 29, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
March 26, 2020
Record last verified: 2020-03