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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285554
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Metavention

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: iRF System Hepatic Denervation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study is a prospective, single-arm, multi-center, non-randomized trial
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Prospective, Single-Arm, Multi-Center Study of the Metavention Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : September 1, 2022

Arm Intervention/treatment
Experimental: Hepatic Denervation Device: iRF System Hepatic Denervation
The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the common hepatic artery (CHA).




Primary Outcome Measures :
  1. Rate of Serious Adverse Device Effects [ Time Frame: Index Procedure through 90 days ]
    The incidence rate of serious adverse device effects (SADEs) from time of Index Procedure through 90 days.


Secondary Outcome Measures :
  1. Change in glycemic control: HbA1c [ Time Frame: 30, 90, 180 and 365 days ]
    Change from baseline in glycemic control as indicated by HbA1c blood test

  2. Change in glycemic control - FPG [ Time Frame: 30, 90, 180 and 365 days ]
    Change from baseline in glycemic control as indicated by fasting plasma glucose blood test

  3. Change in glycemic control - Insulin [ Time Frame: 30, 90, 180 and 365 days ]
    Change from baseline in glycemic control as indicated by insulin blood test during Mixed Meal Tolerance Test

  4. Change in glycemic control - C-peptide [ Time Frame: 30, 90, 180 and 365 days ]
    Change from baseline in glycemic control as indicated by c-peptide blood test during Mixed Meal Tolerance Test

  5. Change in office blood pressure [ Time Frame: 30, 90, 180 and 365 days ]
    Change from baseline in office blood pressure: systolic and diastolic

  6. Change in liver steatosis [ Time Frame: 90 and 365 days ]
    Change from baseline in liver steatosis from baseline as measured using MRI-PDFF

  7. Adverse Event rate 365 days [ Time Frame: Consent through 365 days ]
    Adverse Event rate: Summary of all reported adverse events during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥22 and ≤65 years old
  2. Type 2 Diabetes diagnosis meeting the following criteria:

    1. Hb1Ac > 7.0% and ≤ 9.0% (53 mmol/mol - 75 mmol/mol), AND
    2. On two OAD medications; one at the highest tolerated dose with no changes in medication dose in the 12 weeks prior to the first screening visit
  3. Waist circumference ≥102 cm (male) and ≥88cm (female)
  4. Diagnosis of hypertension: SBP ≥140mmHg OR SBP ≥130mmHg on hypertension medications (2 or less)
  5. MRI-PDFF ≥10% indicating non-alcoholic fatty liver disease (NAFLD)
  6. Documented status of stable lifestyle modifications
  7. Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study

Exclusion Criteria:

  1. BMI >40 kg/m2
  2. Diagnosis of type 1 diabetes
  3. Current or previous use of injectable diabetes medications (e.g., insulin and GLP-1RA)
  4. Current use of >2 hypertension medications
  5. 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
  6. One or more documented hyperglycemia episodes requiring hospitalization in the 180-days prior to Index Procedure
  7. 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)
  8. 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
  9. Any surgical procedure within 30 days prior to Index Procedure
  10. History of gallstones without a cholecystectomy being performed or current gallstones (Note: subjects who have had a cholecystectomy are not excluded)
  11. Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the common hepatic artery
  12. 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:

    1. Systemic Corticosteroids
    2. Anticonvulsants
    3. Centrally acting sympatholytics
  13. Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14 days after the Index Procedure
  14. Any other condition(s) that would compromise the safety of the Subject or compromise study quality as judged by the Investigator
  15. eGFR <60 mL/min/1.73 m2
  16. 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)
  17. Unstable cardiovascular disease, myocardial infarction, unstable angina, widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
  18. 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 Baseline they may enter study
  19. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <100,000/microliter, or documented coagulopathy
  20. 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
  21. Active substance abuse, based on Investigator judgment, including inhaled or injected drugs, within 1 year prior to the initial screening
  22. Significant weight loss within the last 6 months (e.g., >10% total body weight loss)
  23. Hepatic decompensation defined as the presence of any of the following:

    1. Serum albumin less than 3.5 g/dL
    2. International normalized ratio (INR) greater than 1.4 (unless due to therapeutic anticoagulants)
    3. Total bilirubin greater than 2 mg/dL with the exception of Gilbert syndrome
    4. History of esophageal varices, ascites, or hepatic encephalopathy
  24. ALT or AST greater than 200 U/L
  25. Diagnosis of liver cirrhosis
  26. Chronic liver or biliary disease of the following etiology:

    1. History or diagnosis of Hepatitis B
    2. History or diagnosis of Hepatitis C
    3. History or diagnosis of current active autoimmune hepatitis
    4. History or diagnosis of primary biliary cholangitis (PBC)
    5. History or diagnosis of primary sclerosing cholangitis
    6. History or diagnosis of Wilson's disease
    7. History or diagnosis of alpha-1-antitrypsin deficiency
    8. History or diagnosis of hemochromatosis
    9. History or evidence of drug-induced liver disease, as defined on the basis of typical exposure and history
    10. Known bile duct obstruction
    11. Suspected or proven liver cancer
  27. History of acute or chronic pancreatitis
  28. Subjects unable to undergo MRI-PDFF or CT for any reason
  29. Currently enrolled in any other investigational trial
  30. History of an acute neurologic event including epilepsy, seizures, stroke, and transient ischemic attack.
  31. Iliac/femoral artery stenosis precluding insertion of the catheter
  32. Human immunodeficiency virus (HIV)
  33. Subjects with a history of adverse reaction to heparin or heparin induced thrombocytopenia (HIT)
  34. Subjects with conditions that can affect RBC turnover, those who have received a blood transfusion in the past 90 days, or expect to have an elective procedure during the course of the study that may require blood transfusion
  35. Not a candidate for surgery or general anesthesia
  36. Unwilling to comply with study requirements, including medication run-in, SMBG, patient diary and follow-up visits
  37. Subjects with implantable pacemakers, implantable cardiac defibrillators or implantable neurostimulators Anatomic Exclusions from CT Angiogram
  38. Replaced or accessory LHA or RHA determined on CT angiogram.
  39. Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the device from the femoral artery to the target location
  40. Evidence of CHA and/or portal vein intraluminal thrombus
  41. CHA vessel diameter <4.0mm or >7.0mm
  42. CHA diameter stenosis >30%
  43. CHA vessel length <20mm

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): NCT04285554


Contacts
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Contact: Megan Brandt +1-612-814-8204 mbrandt@metavention.com

Locations
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United States, Alabama
Cardiology, P.C. Not yet recruiting
Birmingham, Alabama, United States, 35211
Contact: Susan DeRamus, RN, Clinical Research Director    205-949-5275    sderamus@cardiologypc.com   
Principal Investigator: Farrell Mendelsohn, MD         
United States, California
Stanford University Medical Center Not yet recruiting
Stanford, California, United States, 94305
Contact: Hillary Ta    650-721-0372    hta@stanford.edu   
Contact: Maria Perlas, RN    650-723-2094    mperlas@stanford.edu   
Principal Investigator: Bryant Lin, MD         
Sub-Investigator: David P Lee, MD         
Sub-Investigator: Marina Basina, MD         
United States, Florida
AdventHealth Translational Research Institute Not yet recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department    407-303-7100    Fh.tri.recruitment@adventhealth.com   
Contact: Kory Grench    407-303-7100    kory.grench@adventhealth.com   
Principal Investigator: Richard Pratley, MD         
Sub-Investigator: Rohit Bhatheja, MD         
Sub-Investigator: Heather Richmond, PA-C         
Sub-Investigator: Tina Thethi, MD         
United States, Illinois
Prairie Education & Research Cooperative (PERC) Recruiting
Springfield, Illinois, United States, 62701
Contact: Mark Sanders    217-546-2064    MSanders@prairieresearch.com   
Contact: Gwen Sondgeroth, RN    217-546-2064    Gsondgeroth@prairieresearch.com   
Principal Investigator: Krishna Rocha-Singh, MD         
Sub-Investigator: Diana Widicus, MD         
United States, Minnesota
Mercy Hospital Not yet recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Brittany Renier, RN    763-427-9980      
Contact: Jeff Chambers, MD    763-427-9980      
Principal Investigator: Jeff Chambers, MD         
Sub-Investigator: Chris Martin, MD         
Sponsors and Collaborators
Metavention
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Responsible Party: Metavention
ClinicalTrials.gov Identifier: NCT04285554    
Other Study ID Numbers: 932
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Metavention:
Metabolic Syndrome
NAFLD
Hypertension
High Blood Pressure
Glycemic Control
Diabetes
Denervation
Sympathetic Nervous System
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases