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

Southeast University

Status: Enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Device: Endovascular Denervation System (Netrod)

Study type: Interventional

Funder types: Other

Identifiers

NCT05673668

EDN-T2DM

Details and patient eligibility

About

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) .

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

The endovascular denervation (EDN) group

Experimental group

Description:

Receive endovascular denervation (EDN) treatment

Treatment:

Device: Endovascular Denervation System (Netrod)