Endovascular Denervation (EDN) for the Treatment of Type 2 Diabetes Mellitus

NCT ID: NCT05673668

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2024-04-30

Brief Summary

This is a prospective, single-center, single-arm, self-controlled study to evaluate the effects of endovascular denervation (EDN) on insulin secretory function and insulin sensitivity in the treatment of type 2 diabetes mellitus (T2DM) .

Detailed Description

This is a prospective, single-center, single-arm, self-controlled study. Patients with diagnosed T2DM and poor glycemic control (i.e.. glycated hemoglobin A1c (HbA1c) between 7.5% and 10.5% despite one to three oral antidiabetic drugs (OAD) and/or insulin on the basis of metformin. All included subjects will accept EDN treatment and were followed up at 7, 30 days and 3, 6, 12 months. The primary objectives were evaluate the effects of EDN on insulin secretory function and insulin sensitivity in the treatment of T2DM.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The endovascular denervation (EDN) group

Receive endovascular denervation (EDN) treatment

Group Type: EXPERIMENTAL

Endovascular Denervation System (Netrod)

Intervention Type: DEVICE

The Netrod system is a percutaneous, catheter- based device which uses radiofrequency energy to denervate the sympathetic nerves surrounding the arteries

Interventions

Endovascular Denervation System (Netrod)

The Netrod system is a percutaneous, catheter- based device which uses radiofrequency energy to denervate the sympathetic nerves surrounding the arteries

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject with age of #18 years old and#75 years old (both ends included)

2. Subject (or legal guardian) understands the requirements and treatment of this clinical trial and agrees to and is able to complete the trial

3. Diagnosed with T2DM for ≤15 years (according to WHO criteria)

4. On the basis of metformin (daily dose ≥1000mg), using a combination of 1-3 OADs for more than last 3 months, with or without insulin (dose not limited). Defined OADs were: sulfonylureas/ glienides, thiazolidinediones and α-glycosidase inhibitors

5. Glycosylated hemoglobin (HbA1c) levels between 7.5% and 10.5% (based on baseline tests)

6. Body mass index (BMI) ≥ 18 and ≤40kg/m2

Exclusion Criteria

1. T1DM or any secondary diabetes

2. History of aortic disease (such as aortic aneurysm or aortic dissection) or aortic surgery (including celiac artery dissection)

3. Baseline CTA examination revealed aortic aneurysm or aortic dissection, or abnormal anatomical structure of hepatic artery and its branches, or other vascular structure/status abnormalities (such as severe tortuosity or narrowing of the artery, endovascular thrombosis or unstable plaque, etc.) that were not suitable for endovascular denervation as determined by the researcher

4. More than 2 self-reported or documented events of severe hypoglycemia (defined as hypoglycemia with severe cognitive impairment requiring assistance) within the past 6 months

5. Patients who had a major cardiovascular and cerebrovascular event (MACCE), major surgery, severe infection, gastrointestinal bleeding, and acute pancreatitis in the past 6 months

6. Severe autonomic neuropathy (postural hypotension, etc.)

7. Severe liver insufficiency (ALT and/or AST above 3 times the normal upper limit or serum total bilirubin above 2 times the normal upper limit), renal insufficiency (eGFR < 60mL/ min/1.73m2). eGFR calculation formula is shown in Note e of Table 4.3 Data collection table.), chronic pancreatitis, cocoagulation disorder (PT, APTT or INR higher than 2 times of the normal upper limit; Platelet count < 80×109/L or ≥ 700×109/L) and malignant tumors

8. Suffering from mental illness and unable to cooperate

9. Pregnant

10. There were conditions that the researchers determined will affect the safety of the subjects or interfere with the evaluation of the test results

11. Patients not eligible for MRI (e.g. paramagnetic metal implants, claustrophobia, etc.)

12. Participating in or currently participating in other clinical studies within 3 months prior to enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao-jun Teng

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaojun Teng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhi Wang, MD

Role: CONTACT

wangzhiseu@163.com

+8618652918783

Facility Contacts

Gaojun Teng, MD

Role: primary

Other Identifiers

EDN-T2DM

Identifier Type: -

Identifier Source: org_study_id