Status:
UNKNOWN
The MILESTONE Study
Lead Sponsor:
Zhongda Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 insu...
Detailed 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 studi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04086043
Start Date
September 10 2019
End Date
December 31 2022
Last Update
September 11 2019
Active Locations (1)
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1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009