Clinical trial NCT04086043: The MILESTONE Study
Official title: MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Oral Glucose Tolerance Test from baseline to 6 months
timeFrame: 6 months
measure: Changes in glycosylated hemoglobin from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Oral Glucose Tolerance Test up to 2 years
timeFrame: 3, 12 and 24 months
measure: Changes in glycosylated hemoglobin up to 2 years
timeFrame: 3, 12 and 24 months
measure: Changes in insulin up to 2 years
timeFrame: 3, 6, 12 and 24 months
measure: Changes in catecholamine up to 2 years
timeFrame: 3, 6, 12 and 24 months
measure: Changes in glucagon up to 2 years
timeFrame: 3, 6, 12 and 24 months
measure: Changes in blood pressure up to 2 years
timeFrame: 3, 6, 12 and 24 months
measure: Changes in creatinine up to 2 years
timeFrame: 3, 6, 12 and 24 months
measure: Changes in blood urea nitrogen (BUN) up to 2 years
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
References: