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

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) .

Inclusion Criteria:Subject with age of #18 years old and#75 years old (both ends included)Subject (or legal guardian) understands the requirements and treatment of this clinical trial and agrees to and is able to complete the trialDiagnosed with T2DM for ≤15 years (according to WHO criteria)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 inhibitorsGlycosylated hemoglobin (HbA1c) levels between 7.5% and 10.5% (based on baseline tests)Body mass index (BMI) ≥ 18 and ≤40kg/m2Exclusion Criteria:T1DM or any secondary diabetesHistory of aortic disease (such as aortic aneurysm or aortic dissection) or aortic surgery (including celiac artery dissection)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 researcherMore than 2 self-reported or documented events of severe hypoglycemia (defined as hypoglycemia with severe cognitive impairment requiring assistance) within the past 6 monthsPatients who had a major cardiovascular and cerebrovascular event (MACCE), major surgery, severe infection, gastrointestinal bleeding, and acute pancreatitis in the past 6 monthsSevere autonomic neuropathy (postural hypotension, etc.)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 tumorsSuffering from mental illness and unable to cooperatePregnantThere were conditions that the researchers determined will affect the safety of the subjects or interfere with the evaluation of the test resultsPatients not eligible for MRI (e.g. paramagnetic metal implants, claustrophobia, etc.)Participating in or currently participating in other clinical studies within 3 months prior to enrollment