Diabetes Mellitus, Type 2DeLIVERNCT04285554
Evaluation of the Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects
A study testing iRF System Hepatic Denervation in people with Diabetes Mellitus, Type 2, run by Metavention at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- iRF System Hepatic Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Jul 2020to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
- Hepatic decompensation defined as the presence of any of the following:
- Serum albumin less than 3.5 g/dL
- International normalized ratio (INR) greater than 1.4 (unless due to therapeutic anticoagulants)
- Total bilirubin greater than 2 mg/dL with the exception of Gilbert syndrome
- History of esophageal varices, ascites, or hepatic encephalopathy
- ALT or AST greater than 200 U/L
- Diagnosis of liver cirrhosis
- Chronic liver or biliary disease of the following etiology:
- History or diagnosis of Hepatitis B
- History or diagnosis of Hepatitis C
- History or diagnosis of current active autoimmune hepatitis
- History or diagnosis of primary biliary cholangitis (PBC)
- History or diagnosis of primary sclerosing cholangitis
- History or diagnosis of Wilson's disease
- History or diagnosis of alpha-1-antitrypsin deficiency
- History or diagnosis of hemochromatosis
- History or evidence of drug-induced liver disease, as defined on the basis of typical exposure and history
- Known bile duct obstruction
- Suspected or proven liver cancer
- History of acute or chronic pancreatitis
- Subjects unable to undergo CT for any reason
- Currently enrolled in any other investigational trial
- History of an acute neurologic event including epilepsy, seizures, stroke, and transient ischemic attack.
- Iliac/femoral artery stenosis precluding insertion of the catheter
- Human immunodeficiency virus (HIV)
- Subjects with a history of adverse reaction to heparin or heparin induced thrombocytopenia (HIT)
- 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
- Not a candidate for surgery or general anesthesia
- Unwilling to comply with study requirements, including medication run-in, SMBG, patient diary and follow-up visits
- Subjects with implantable pacemakers, implantable cardiac defibrillators or implantable neurostimulators
- Anatomic Exclusions from CT Angiogram
- Replaced or accessory LHA or RHA determined on CT angiogram.
- Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the device from the femoral artery to the target location
- Evidence of CHA and/or portal vein intraluminal thrombus
- CHA vessel diameter <4.0mm or >7.0mm
- CHA diameter stenosis >30%
- CHA vessel length <20mm
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cardiology, P.C.
Birmingham, Alabama, 35211
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433
Soltero Cardiovascular Research Center
Dallas, Texas, 75226
UPMC Pinnacle
Harrisburg, Pennsylvania, 17011
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135
AdventHealth Translational Research Institute
Orlando, Florida, 32804
Prairie Education & Research Cooperative (PERC)
Springfield, Illinois, 62701
Stanford University Medical Center
Stanford, California, 94305
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- iRF System Hepatic Denervation
- Keywords
- Metabolic Syndrome, NAFLD, Hypertension, High Blood Pressure, Glycemic Control, Diabetes, Denervation, Sympathetic Nervous System
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRF System Hepatic DenervationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Denervation | Experimental | Not described Receives: Device: iRF System Hepatic Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Device Effects
The incidence rate of serious adverse device effects (SADEs) from time of Index Procedure through 90 days.
Measured: Index Procedure through 90 days
Secondary outcomes (7)
Change in glycemic control: HbA1c
Change from baseline in glycemic control as indicated by HbA1c blood test
Measured: 30, 90, 180 and 365 days
Change in glycemic control - FPG
Change from baseline in glycemic control as indicated by fasting plasma glucose blood test
Measured: 30, 90, 180 and 365 days
Change in glycemic control - Insulin
Change from baseline in glycemic control as indicated by insulin blood test during Mixed Meal Tolerance Test
Measured: 30, 90, 180 and 365 days
Change in glycemic control - C-peptide
Change from baseline in glycemic control as indicated by c-peptide blood test during Mixed Meal Tolerance Test
Measured: 30, 90, 180 and 365 days
Change in office blood pressure
Change from baseline in office blood pressure: systolic and diastolic
Measured: 30, 90, 180 and 365 days
Change in liver steatosis
Change from baseline in liver steatosis from baseline as measured using MRI-PDFF
Measured: 90 and 365 days
Adverse Event rate 365 days
Adverse Event rate: Summary of all reported adverse events during the study
Measured: Consent through 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start28 Jul 2020
- Primary completion2 Mar 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective, single-arm, multi-center, non-randomized trial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metavention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285554
- Sponsor's protocol ID
- 932
- Acronym
- DeLIVER
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04285554
- Acronym / sponsor ID
- DeLIVER / 932
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Metabolic Syndrome, NAFLD, Hypertension, High Blood Pressure, Glycemic Control, Diabetes, Denervation, Sympathetic Nervous System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MetaventionIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, single-arm, multi-center, non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Hepatic Denervation | Experimental | Device: iRF System Hepatic Denervation |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥22 and ≤70 years old
- Type 2 diabetes diagnosis meeting the following criteria:
- 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
Key exclusion criteria (62 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iRF System Hepatic DenervationThe iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the common hepatic artery (CHA). | Device | Hepatic Denervation |
Primary outcome
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.
7 secondary outcomes
Change in glycemic control: HbA1c
Time frame: 30, 90, 180 and 365 days
Change in glycemic control - FPG
Time frame: 30, 90, 180 and 365 days
Change in glycemic control - Insulin
Time frame: 30, 90, 180 and 365 days
Change in glycemic control - C-peptide
Time frame: 30, 90, 180 and 365 days
Change in office blood pressure
Time frame: 30, 90, 180 and 365 days
Change in liver steatosis
Time frame: 90 and 365 days
Adverse Event rate 365 days
Time frame: Consent through 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRF System Hepatic Denervation in people with Diabetes Mellitus, Type 2, run by Metavention at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 62 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Adverse Device Effects (time frame: Index Procedure through 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.