| Eligibility |
Inclusion Criteria:
1. Age =22 and =70 years old
2. Type 2 diabetes diagnosis meeting the following criteria:
1. HbA1c > 7.0% and = 9.0% (53 mmol/mol - 75 mmol/mol), AND
2. 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
3. Waist circumference =102 cm (male) and =88cm (female)
4. Diagnosis of hypertension: SBP =140mmHg OR SBP =130mmHg on hypertension medication(s)
5. Documented status of stable lifestyle modifications
6. 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. Use of insulin within 90 days of consent
4. 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
5. One or more documented hyperglycemia episodes requiring hospitalization in the
180-days prior to Index Procedure
6. 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)
7. 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
8. Any surgical procedure within 30 days prior to Index Procedure
9. 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)
10. Previous hepatobiliary surgery/intervention that in the opinion of the investigator
could preclude the ability to perform denervation of the common hepatic artery
11. 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
12. Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14
days after the Index Procedure
13. Any other condition(s) that would compromise the safety of the Subject or compromise
study quality as judged by the Investigator
14. eGFR <45 mL/min/1.73 m2
15. 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)
16. Myocardial infarction, unstable angina within 1 year prior to consent
17. 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 Screening 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 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
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