Diabetes Mellitus, Type 2 study: Ablation Treatment vs Arterial Angiography Only
Official title Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
ClinicalTrials.gov ID: NCT05369065
What this study is testing
What is Ablation Treatment?
Ablation Treatment is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for diabetes mellitus, type 2.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is to assess the safety and performance of the Neurotronic Infusion Catheter and ethanol denervation of renal and hepatic arteries for the treatment of patients with Type 2 Diabetes (T2DM), Hypertension and Obesity.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Age ≥ 21 and ≤ 65 years at time of enrollment.
- Fasting plasma glucose ≥ 140 mg/dl (7.8 mmol/l) and ≤ 270 mg/dL (15 mmol/L)
- HbA1c levels ≥ 7.0% and ≤ 9.0% (53-75 mmol/mol)
- Triglyceride level \< 400 mg/dL (4.52 mmol/L)
- On oral anti-hyperglycemic drug regimen of metformin. people may be on additional oral anti-hyperglycemic drug of a different drug class
You likely can't join if
- T1DM or poorly controlled T2DM (defined as HbA1c \> 9.0% or use insulin as medication to control glucose level).
- Office diastolic blood pressure \< 90 mmHg.
- Current use of \> 3 hypertension medications.
- Currently on beta blockers or alpha blockers.
- One or more documented hyperglycemia episodes requiring hospitalization in the 180-day prior to screening date.
- Prior evidence of hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in...
See the full eligibility criteria
Who can join
- Age ≥ 21 and ≤ 65 years at time of enrollment.
- Fasting plasma glucose ≥ 140 mg/dl (7.8 mmol/l) and ≤ 270 mg/dL (15 mmol/L)
- HbA1c levels ≥ 7.0% and ≤ 9.0% (53-75 mmol/mol)
- Triglyceride level \< 400 mg/dL (4.52 mmol/L)
- On oral anti-hyperglycemic drug regimen of metformin. people may be on additional oral anti-hyperglycemic drug of a different drug class
- Years of T2DM ≤ 10 years
- Office blood pressure of SBP of ≥ 140 mmHg and ≤ 180 mmHg and DBP ≥ 90 mmHg
- Mean 24-hour ambulatory SBP of ≥ 130 mmHg and ≤ 170 mmHg with ≥ 75% valid readings
- On stable oral anti-hypertension drug regimen consisting of up to a maximum of three drugs
- BMI between 27.5 and 40 kg/m2
- C-peptide testing: non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/L)
- Renal
- Hepatic
What rules you out
- T1DM or poorly controlled T2DM (defined as HbA1c \> 9.0% or use insulin as medication to control glucose level).
- Office diastolic blood pressure \< 90 mmHg.
- Current use of \> 3 hypertension medications.
- Currently on beta blockers or alpha blockers.
- One or more documented hyperglycemia episodes requiring hospitalization in the 180-day prior to screening date.
- Prior evidence of hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months.
- BMI \> 40 kg/m2.
- Diagnosed proliferative retinopathy or evidence of peripheral neuropathy.
- Lack of appropriate treatment site or anatomy precluding the intervention of the target arteries (renal and hepatic artery).
- History of prior renal or hepatic artery intervention including balloon angioplasty, stenting, etc.
- Arterial stenosis \>50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).
- Any abnormality or disease in one or more of the target arteries that, per the physician assessment, precludes the safe insertion of the guiding catheter (including, but not limited to, artery aneurysm, excessive...
- Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure.
- Known or suspected secondary hypertension, such as Cushing's disease or Cushing's Syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, history of pre-eclampsia, onset of hypertension...
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
- Severe or unstable cardiovascular comorbidities, such as AMI or ACS, cardiac valve stenosis, pulmonary embolism, heart failure with NYHA Class III or IV, chronic atrial fibrillation, primary pulmonary hypertension, COPD.
- Renal transplant, history of nephrectomy or single kidney, renal tumor/cancer, known non-functioning kidney, unequal renal size (\>2 cm difference in renal length between kidneys associated with a chronic kidney disease...
- Prior liver transplant.
- Any organ transplantation procedures are planned in the 365 days following Index Procedure.
- Gastrointestinal permanent anatomic alteration surgery.
- Any surgical procedure within 30 days prior to Index Procedure.
- Systemic Corticosteroids
- Anticonvulsants
- Centrally acting sympatholytics
- Bleeding disorders, such as bleeding diathesis, thrombocytopenia, and severe anemia.
- Use of anticoagulation therapy which cannot be discontinued from 7 days before or 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.
- 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 judgement, 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).
- Serum albumin less than 3.5 g/dL
- International normalization 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.
- 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
- 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 diagnosis 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.
- Human immunodeficiency virus (HIV).
- people with a history of adverse reaction to heparin or heparin induced thrombocytopenia (HIT).
- Systemic infection that the investigator judges would pose unacceptable procedural risks to the subject.
- Known hypersensitivity to contrast media, nickel and ethanol that cannot be adequately pre-medicated.
- Subject is depressed or on antidepressants.
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Life expectancy of less than 5 years.
- Unwilling or unable to comply with the follow-up study requirements.
- Lacking capacity to provide informed consent.
- Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
- Currently participation in another pre-market drug or medical device clinical study
The study team makes the final eligibility decision.
Where it is enrolling
- Tbilisi, Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tbilisi, Georgia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.