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

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ClinicalTrials.gov Identifier: NCT02278068
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Endocrine, Nutritional and Metabolic Diseases (E00-E89) Device: Metabolic Neuromodulation System (MNS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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 Name: Hepatic sympathetic denervation




Primary Outcome Measures :
  1. Primary Safety Outcome as assessed by Incidence of serious adverse device effects [ Time Frame: 180 day follow-up ]
    Incidence of serious adverse device effects


Secondary Outcome Measures :
  1. Device and Procedural success [ Time Frame: intra operative ]
    Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure

  2. 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

  3. Laboratory Assessments/Cardiometabolic Changes [ Time Frame: 180 day follow up ]
    Assessment of chemistry/serum lab values to evaluate safety and performance

  4. Adverse Event Rate [ Time Frame: 365 day follow up ]
    Summary of all reported adverse events during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278068


Locations
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New Zealand
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
Sponsors and Collaborators
Metavention
Investigators
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Principal Investigator: Mark Webster, Prof Auckland City Hospital

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Responsible Party: Metavention
ClinicalTrials.gov Identifier: NCT02278068    
Other Study ID Numbers: MV-2014-ANZ-001
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Keywords provided by Metavention:
Type 2 diabetes
Additional relevant MeSH terms:
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Metabolic Diseases