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Completed

NCT Number: NCT02278068

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Endocrine, Nutritional and Metabolic Diseases (E00-E89) Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auckland City Hospital, Auckland, New Zealand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metabolic Neuromodulation System (MNS)

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Metavention

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2014
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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