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

Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278068
• Other study ID #: MV-2014-ANZ-001
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 2019

Study information

• Verified date: March 2020
• Source: Metavention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Endocrine, Nutritional and Metabolic Diseases (E00-E89)
• Metabolic Diseases

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Metavention

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Outcome as assessed by Incidence of serious adverse device effects	Incidence of serious adverse device effects	180 day follow-up
Secondary	Device and Procedural success	Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure	intra operative
Secondary	Glycemic control	Number of subjects with a decrease in HbA1c, change in plasma glucose based on fasting glucose and oral glucose tolerance test	180 day and 365 day follow-up
Secondary	Laboratory Assessments/Cardiometabolic Changes	Assessment of chemistry/serum lab values to evaluate safety and performance	180 day follow up
Secondary	Adverse Event Rate	Summary of all reported adverse events during the study	365 day follow up