Endovascular Denervation for the Treatment of Type 2 Diabetes Mellitus

NCT05631561 | Active Not Recruiting

• 1 other identifier: MLWY-S220501
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, single group feasibility clinical trial to evaluate the safety and efficacy of Endovascular denervation for the treatment of type 2 diabetes mellitus (T2DM) using the Endovascular denervation system (Generator and Catheter).

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes Mellitus; Endovascular denervation

Outcome Measures

Primary Outcomes (2)

• the composite of major adverse events (MAE)* related to the study device and/or the EDN procedure during procedure and within 30 days post procedure

  The primary safety endpoint is the composite of major adverse events (MAE)\* related to the study device and/or the EDN procedure during procedure and within 30 days post procedure

  From index procedure to 30 days post procedure

• The changes of Hba1c from baseline at 6 months post procedure

  The primary efficacy is the changes of Hba1c from baseline at 6 months post procedure.

  From baseline to 6 months post procedure

Secondary Outcomes (15)

• The changes of Hba1c from baseline at 1, 3, 12 and 24 months post procedure

  From baseline to 1, 3, 12 and 24 months post procedure

• The changes of assessment of islet function and insulin resistance at 1, 3, 6, 12 and 24 months post procedure

  From baseline to 1, 3, 6, 12 and 24 months post procedure

• The changes of mean glucose, postprandial glucose increase, nocturnal glucose increase and time in target range (TIR) by 14-day ambulatory glucose monitoring (with non-invasive ambulatory glucose meter) at 1, 3, 6, 12 and 24 months post procedure

  From baseline to 1, 3, 6, 12 and 24 months post procedure

• The changes of blood lipids at 1, 3, 6, 12 and 24 months post procedure

  From baseline to 1, 3, 6, 12 and 24 months post procedure

• The changes of liver function at 1, 3, 6, 12 and 24 months post procedure

  From baseline to 1, 3, 6, 12 and 24 months post procedure

Study Arms (1)

The endovascular denervation (EDN) group

EXPERIMENTAL

Receive endovascular denervation (EDN)

Device: Endovascular denervation System (Generator and Catheter )

Interventions

Endovascular denervation System (Generator and Catheter ) DEVICE

All patients receive endovascular denervation (EDN) treatment

The endovascular denervation (EDN) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with age of \>18 years old and\<65 years old (both ends included)
• Subjects understood the requirements and treatments of the trial, agreed to and were able to complete all follow-up assessments required for the trial, and signed informed consent before any special trial-related tests and treatments were performed
• Diagnosed with T2DM for 1-15 years (according to WHO criteria)
• Metformin (daily dose ≥1000mg) was combined with 1-3 Oads for more than 3 months and/or insulin (no dose limit). Specific Oads were: insulin secretagogues (sulfonylureas/glinides), thiazolidinediones (TZDS) and α-glucosidase inhibitors (see Note), and the combined Oads were at least half of the maximum approved dose in the package insert
• The above OAD treatment is not effective for more than 3 months, and the glycosylated hemoglobin (HbA1c) level is between 7.5% and 10.5% (based on baseline examination)
• Body mass index (BMI) between 18 and 40kg/m2 (both ends included)

You may not qualify if:

• Type 1 diabetes or late-onset autoimmune diabetes in adults (LADA), or any secondary diabetes
• Previous aortic disease (e.g., aortic aneurysm or dissection) or aortic surgery (including celiac artery denervation)
• Baseline CTA showed aortic aneurysm or dissection, or anatomical abnormalities of the hepatic artery and its branches, or other abnormal vascular structure/status (e.g., severe tortuosity or stenosis of the artery, intraval thrombus, or unstable plaque) deemed by the investigator to be unsuitable for vascular ablation.
• More than 2 self-reported or documented episodes of severe hypoglycemia in the past 6 months (defined as hypoglycemia with severe cognitive impairment requiring assistance from another person)
• Have had more than one documented episode of hyperglycemia requiring hospitalization in the past 6 months, including diabetic ketoacidosis, hyperosmolar coma, etc
• Severe diabetic complications, such as retinal, renal, vascular, neuropathy, and diabetic foot, were considered by the investigator to be ineligible for enrollment in this trial
• Major cardiovascular and cerebrovascular events (MACCE) within the past 6 months, including cerebrovascular accident (CVA), transient cerebral ischemia (TIA), heart failure (NYHA class III-IV), acute myocardial infarction, or unstable angina requiring hospitalization (including previous coronary artery bypass grafting or coronary stent implantation); And uncontrolled or severe arrhythmias
• Severe autonomic neuropathy (orthostatic hypotension, gastroparesis syndrome, etc.)
• Untreated or uncontrolled high blood pressure (SBP≥160mmHg or DBP≥100mmHg), or low blood pressure (BP \< 90/50 MMHG)
• A history of renal insufficiency or failure with a baseline estimated glomerular filtration rate (eGFR) \< 60mL/min/1.73m2 (see Note c of the Clinical Data collection Table in Table 5-2 for the eGFR formula)
• Chronic active hepatitis, severe hepatobiliary disease (including cirrhosis), or hepatic insufficiency (alanine and/or aspartate aminotransferase \> 3 times the upper limit of normal or serum total bilirubin \> 2 times the upper limit of normal)
• Acute and chronic pancreatitis during screening and baseline periods
• Acute systemic infections during the screening and baseline periods
• Bleeding tendency or coagulopathy (PT, APTT, or INR \> 2 times the upper limit of normal; Platelet count \< 80×109/L or ≥ 700×109/L)
• Active GI ulcer or GI bleeding within 3 months before baseline

Sponsors & Collaborators

• Shanghai Golden Leaf MedTec Co. Ltd: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• Wang Z, Pan T, Lv W, Tang J, Chen Y, Zhu X, Zhang Q, Jing F, Yin H, Lu D, Zhang L, Liu D, Zhao J, Li L, Weng J, Teng GJ. Catheter-based endovascular celiac and hepatic denervation for type 2 diabetes: a multicenter, open-label, single-arm study. Signal Transduct Target Ther. 2025 Nov 13;10(1):371. doi: 10.1038/s41392-025-02459-6.

  PMID: 41233363 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Radionuclide Generators; Catheters

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiation Equipment and Supplies; Equipment and Supplies

Study Officials

• Gao-Jun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 30, 2022
• Study Start: December 27, 2022
• Primary Completion: April 1, 2024
• Study Completion: February 28, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-03

Locations

CN (1)