Status:
UNKNOWN
Renal Denervation in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Zhongda Hospital
Conditions:
Type 2 Diabetes Mellitus
Renal Denervation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so we assume that renal denervation (RDN) might improve glucose metabolism and insulin sensitivity. The purpose...
Detailed Description
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that renal denervation (RDN) might improve glucose metabolism and insulin sensitivity. Some cl...
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
- Renal arterial anatomy ineligible for RDN: main renal arteries \<4 mm in diameter or \<20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply \<75% of the kidney
- 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 :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03418415
Start Date
January 18 2018
End Date
January 1 2022
Last Update
February 1 2018
Active Locations (1)
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1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009