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Type 2 Diabetes Mellitus (T2DM)NCT05631561

Endovascular Denervation for the Treatment of Type 2 Diabetes Mellitus

A study testing Endovascular denervation System (Generator and Catheter ) in people with Type 2 Diabetes Mellitus (T2DM), run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Endovascular denervation System (Generator and Catheter )
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
27 Dec 2022to 28 Feb 2025
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 41Show fewer
  • 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
  • Symptomatic cholelithiasis (including cholecystolithiasis, extrahepatic bile duct stones, and intrahepatic bile duct stones) but without effective treatment such as cholecystectomy, choledocholithotomy, internal drainage or external drainage
  • Hyperthyroidism, hypothyroidism, acromegaly, Cushing's syndrome and other endocrine and metabolic diseases
  • Autoimmune diseases
  • Diagnosed with a high risk of malignancy or cancer development/recurrence, or expected life expectancy < 12 months
  • History of major surgical procedures within the past 3 months
  • A condition or concomitant medical condition, such as hemoglobinopathy or hemolytic anemia, that could have prevented the primary end point from being assessed
  • Patients with mental illness who are unable to cooperate
  • Received treatment with a GLP-1 receptor agonist, DPP-4 inhibitor, or SGLT-2 inhibitor within 3 months before the screening period
  • Received systemic or intra-articular glucocorticoids (other than topical, inhaled, or eye drops) within 3 months before the screening period
  • Use of weight-loss medications such as orlistat or other possible treatments for weight loss (weight-loss tea/herbal medicine/acupuncture, etc.) within 3 months before the screening period
  • Prior or anticipated bariatric surgery such as subtotal gastrectomy/liposuction
  • Receipt of central sympathetic inhibitors or anticonvulsants within 3 months prior to or anticipated during the screening period
  • Long-term anticoagulation therapy is required but preoperative heparin bridging anticoagulation is not possible
  • Weight gain of more than 10% in the past 3 months
  • Allergy to or contraindication to contrast media, and inadequate pretreatment, as judged by the investigator
  • A known history of allergy to the study device (containing polytetrafluoroethylene or Nitinol) or to medications associated with the trial protocol
  • Were participating in other clinical studies or were participating in clinical studies within 3 months before enrollment
  • Expect to participate in a clinical trial of another drug or medical device within 24 months after baseline surgery
  • Pregnant or lactating women, or those planning to become pregnant within the next 2 years (all women of childbearing age must undergo a pregnancy test within 7 days before baseline surgery)
  • Drastic changes in diet and exercise habits are expected during the study (due to religious/work needs/weight loss, etc.)
  • Irregular day and night work (night shift workers)
  • History of alcohol/drug/substance abuse
  • Scheduled periodic blood product therapy or severe blood loss during the previous 3 months/study period
  • According to the investigator's judgment, there is any situation that affects the safety of the subjects or interferes with the evaluation of the test results
  • Subjects had aortic aneurysm or aortic dissection confirmed on angiography before EDN
  • The subject's vascular structure and conditions were considered by the investigator to be unsuitable for ablation (e.g., severe tortuosity or stenosis of the artery, abnormal vascular anatomy, intracavinal thrombus, or unstable plaque).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Endovascular Denervation for the Treatment of Type 2 Diabetes Mellitus - a Feasible Clinical Trial Protocol

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).

Read the detailed description

This is a prospective, multicenter, single group feasibility clinical trial. Patients with T2DM with poor glycemic control, glycated hemoglobin A1c (Hba1c) between 7.5% and 10.5% treatment with at least one to three oral antidiabetic drugs and/or insulin on the basis of metformin. All eligible patients will accept EDN treatment and were evaluated at 7, 30, 60, 90, 180, 365, 730 days post procedure. The primary safety endpoint is the number of composite major adverse events (MAE) * related to the study device and/or the denervation procedure during procedure and within 30 days after the procedure, the primary efficacy is Hba1c changes from baseline to 6 months post procedure.

Being tested
Endovascular denervation System (Generator and Catheter )
Keywords
Type 2 Diabetes Mellitus, Endovascular denervation
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular denervation System (Generator and Catheter )Device

    All patients receive endovascular denervation (EDN) treatment

Study groups in NCT05631561
Study groupRoleWhat they receive
The endovascular denervation (EDN) groupExperimentalReceive endovascular denervation (EDN)
Receives: Device: Endovascular denervation System (Generator and Catheter )

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From index procedure to 30 days post procedure

  2. 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.

    Measured: From baseline to 6 months post procedure

Secondary outcomes (15)

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

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

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

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

    The change of islet function and insulin resistance (HOMA-β and HOMA-IR) from baseline at 1, 3, 6, 12 and 24 months post procedure

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

  3. 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

    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

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

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

    The changes of blood lipids (triglycerides, total cholesterol, HDL and LDL) from baseline to 1, 3, 6, 12 and 24 months post procedure

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

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

    The changes of blood liver function (ALT, AST, ALP and GGT) from baseline at 1, 3, 6, 12 and 24 months post procedure

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

  6. The changes of renal function to 1, 3, 6, 12 and 24 months post procedure

    The changes of blood renal function (urea nitrogen, blood creatinine and eGFR) from baseline at 1, 3, 6, 12 and 24 months post procedure

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

  7. The changes of glucose in oral glucose tolerance test (OGTT) and insulin and C-peptide release tests from baseline to 6, 12, and 24 months post procedure

    The changes of glucose in oral glucose tolerance test (OGTT) and insulin and C-peptide release tests from baseline to 6, 12, and 24 months post procedure

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

  8. Proportion of patients achieving target HbA1c (< 7.0% and ≤6.5%) at 1, 3, 6, 12 and 24 months post procedure

    Proportion of patients achieving target HbA1c (< 7.0% and ≤6.5%) at 1, 3, 6, 12 and 24 months post procedure

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

  9. Proportion of patients with HbA1c < 7% without hypoglycemia/severe hypoglycemia or weight gain at 1, 3, 6, 12 and 24 months post procedure

    Proportion of patients with HbA1c < 7% without hypoglycemia/severe hypoglycemia or weight gain at 1, 3, 6, 12 and 24 months post procedure

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

  10. Proportion of patients with the changes of in type/dose of antidiabetic drugs at 1, 3, 6, 12 and 24 months post procedure

    Proportion of patients with the changes of in type/dose of antidiabetic drugs at 1, 3, 6, 12 and 24 months post procedure

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

  11. Incidence of hypoglycemia and severe hypoglycemia (blood glucose level < 3.9 mmol/L) at 1, 3, 6, 12 and 24 months post procedure

    Incidence of hypoglycemia and severe hypoglycemia (blood glucose level < 3.9 mmol/L) at 1, 3, 6, 12 and 24 months post procedure

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

  12. The occurrence of new significant celiac or hepatic artery stenosis at 6 months post procedure (stenosis >50% as assessed by CTA and confirmed by DSA when CTA assessment shows abnormal)

    The occurrence of new significant celiac or hepatic artery stenosis at 6 months post procedure (stenosis >50% as assessed by CTA and confirmed by DSA when CTA assessment shows abnormal)

    Measured: From baseline to 7days, 1, 3, 6, 12 and 24 months post procedure

  13. The occurrence of device and/or procedure-related AEs and SAEs during procedure and 7 days, 1, 3, 6, 12 and 24 months post procedure

    The occurrence of device and/or procedure-related AEs and SAEs during procedure and 7 days, 1, 3, 6, 12 and 24 months post procedure

    Measured: From baseline to 12 and 24 months post procedure

  14. Incidence of cardiovascular and cerebrovascular complications (3MACE, defined as cardiovascular death, myocardial infarction and ischemic stroke) at 12 and 24 months post procedure

    Incidence of cardiovascular and cerebrovascular complications (3MACE, defined as cardiovascular death, myocardial infarction and ischemic stroke) at 12 and 24 months post procedure

    Measured: From baseline to 12 and 24 months post procedure

  15. Quality of life assessment (EQ-5D-5L) at pre-procedure and 6 months post procedure

    Quality of life assessment (EQ-5D-5L) at pre-procedure and 6 months post procedure

    Measured: Before procedure to 6 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start27 Dec 2022
  3. Primary completion1 Apr 2024
  4. Study completion28 Feb 2025 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05631561
Sponsor's protocol ID
MLWY-S220501
Status last verified
Mar 2024
First submitted
13 Nov 2022
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41233363

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular denervation System (Generator and Catheter ) in people with Type 2 Diabetes Mellitus (T2DM), run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.

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 6 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

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?

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 (time frame: From index procedure to 30 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05631561, which also lists 1 linked publication.

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 9 Apr 2024.

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