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

Metavention

Status

Completed

Conditions

Diabetes

Endocrine, Nutritional and Metabolic Diseases (E00-E89)

Treatments

Device: Metabolic Neuromodulation System (MNS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02278068

MV-2014-ANZ-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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