Evaluation of the Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

The objective of this early feasibility study is to evaluate the safety and performance of intravascular hepatic denervation using the Metavention Integrated Radio Frequency Denervation System (iRF System) to improve glycemic control in type 2 diabetes subjects.

Key facts

Study ID

NCT04285554

Run by

Metavention

People needed

15

Starts

2020-07-28

Expected to finish

2022-12-19

Last updated by the study team

2023-03-15

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥22 and ≤70 years old
• Type 2 diabetes diagnosis meeting the following criteria:
• HbA1c > 7.0% and ≤ 9.0% (53 mmol/mol - 75 mmol/mol), AND
• On at least two anti-diabetic medications; one at the highest tolerated dose with no changes in medication dose in the 12 weeks prior to the first screening visit
• Waist circumference ≥102 cm (male) and ≥88cm (female)
• Diagnosis of hypertension: SBP ≥140mmHg OR SBP ≥130mmHg on hypertension medication(s)
• Documented status of stable lifestyle modifications
• Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study

You may not qualify if…

• BMI >40 kg/m2
• Diagnosis of type 1 diabetes
• Use of insulin within 90 days of consent
• Two or more self-reported or documented severe hypoglycemia events (severe hypoglycemia event defined as: hypoglycemia associated with severe cognitive impairment requiring external assistance for recovery) in the 180 days prior to Index Procedure
• One or more documented hyperglycemia episodes requiring hospitalization in the 180-days prior to Index Procedure
• During medication run in period, uncontrolled hyperglycemia noted by a fasting glucose value of >270mg/dL or >360mg/dL at any point that is then confirmed by a second measurement (not on the same day)
• A history of bariatric surgery, renal denervation, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
• Any surgical procedure within 30 days prior to Index Procedure
• History of or current symptomatic gallstones (e.g., cholecystitis, bile duct dilatation) without a cholecystectomy being performed (Note: subjects who have had a cholecystectomy are not excluded)
• Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the common hepatic artery
• Currently taking the following medications within 90 days prior to screening and/or there is a need or anticipated need for these medications during the study:
• Systemic corticosteroids
• Anticonvulsants
• Centrally acting sympatholytics
• Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14 days after the Index Procedure
• Any other condition(s) that would compromise the safety of the Subject or compromise study quality as judged by the Investigator
• eGFR <45 mL/min/1.73 m2
• History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy (e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)
• Myocardial infarction, unstable angina within 1 year prior to consent
• Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
• Documented history or concurrent signs of significant thyroid disease NOTE: If a subject is on chronic thyroid drug treatment, and has a serum TSH test result in normal range at Screening they may enter study
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <100,000/microliter, or documented coagulopathy
• Significant alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to reliably quantify alcohol intake
• Active substance abuse, based on Investigator judgment, including inhaled or injected drugs, within 1 year prior to the initial screening
• Significant weight loss within the last 6 months (e.g., >10% total body weight loss)

Where it is running

• Cardiology, P.C. — Birmingham, Alabama, United States
• Stanford University Medical Center — Stanford, California, United States
• AdventHealth Translational Research Institute — Orlando, Florida, United States
• Prairie Education & Research Cooperative (PERC) — Springfield, Illinois, United States
• Metropolitan Cardiology Consultants — Coon Rapids, Minnesota, United States
• South Oklahoma Heart Research, LLC — Oklahoma City, Oklahoma, United States
• UPMC Pinnacle — Harrisburg, Pennsylvania, United States
• Soltero Cardiovascular Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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