The MILESTONE Study

Southeast University

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: Endovascular Denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT04086043

EDNT2DM-2019

Details and patient eligibility

About

Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might reduce sympathetic overactivity and improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.

Full description

Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might improve glucose metabolism and insulin sensitivity. Some clinical studies have shown that glucose metabolism is improved in patients with resistant hypertension both 1 and 3 months after denervation, and fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. But in some clinical studies, denervation did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after denervation. Therefore, the efficacy of denervation on glucose metabolism is still in controversy. The investigators wish to investigate the effect of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years and ≤ 70 years old
• Able and willing to provide informed consent
• Patients with established type II diabetes mellitus (HbA1C>7.5%, diet or oral hypoglycaemic agents)
• Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
• Anticipated that patients are able to maintain a stable dose of medication for the duration of the study

Exclusion criteria

• Arterial anatomy ineligible for endovascular denervation
• History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation
• Type 1 diabetes mellitus
• Pregnant, nursing or planning to be pregnant
• Orthostatic hypotension
• eGFR <30 ml/min (MDRD formula)
• Patients that have allergy to contrast agent
• Myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
• Cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion
• Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Endovascular Denervation

Experimental group

Treatment:

Device: Endovascular Denervation