Endovascular denervation for treating type 2 diabetes

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

This study is testing if a new treatment called endovascular denervation can help people with type 2 diabetes who struggle to control their blood sugar.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhongda Hospital (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05673668 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of endovascular denervation (EDN) on insulin secretory function and insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) who have poor glycemic control. It is a prospective, single-center, single-arm, self-controlled study involving patients aged 18 to 75 years diagnosed with T2DM for up to 15 years. Participants will receive EDN treatment and will be monitored at various intervals over a year to assess changes in their diabetes management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with type 2 diabetes poorly controlled on metformin and other oral antidiabetic medications.

Not a fit: Patients with type 1 diabetes or secondary diabetes, as well as those with a history of aortic disease, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve insulin sensitivity and glycemic control in patients with type 2 diabetes.

How similar studies have performed: While the approach of endovascular denervation is novel, similar studies in related fields have shown promising results, indicating potential for success.

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

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Gaojun Teng, MD — Zhongda Hospital
• Study coordinator: Zhi Wang, MD

Conditions: Type 2 Diabetes Mellitus, Endovascular denervation