The MILESTONE Study

Overview

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 Title of Study: “MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 9, 2022

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.

Interventions

  • Device: Endovascular Denervation
    • multi-electrode catheter-based endovascular denervation

Arms, Groups and Cohorts

  • Experimental: Endovascular Denervation

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Oral Glucose Tolerance Test from baseline to 6 months
    • Time Frame: 6 months
    • To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
  • Changes in glycosylated hemoglobin from baseline to 6 months
    • Time Frame: 6 months
    • To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).

Secondary Measures

  • Changes in Oral Glucose Tolerance Test up to 2 years
    • Time Frame: 3, 12 and 24 months
    • To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
  • Changes in glycosylated hemoglobin up to 2 years
    • Time Frame: 3, 12 and 24 months
    • To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
  • Changes in insulin up to 2 years
    • Time Frame: 3, 6, 12 and 24 months
    • To investigate the influence of endovascular denervation on insulin.
  • Changes in catecholamine up to 2 years
    • Time Frame: 3, 6, 12 and 24 months
    • To investigate the influence of endovascular denervation on catecholamine.
  • Changes in glucagon up to 2 years
    • Time Frame: 3, 6, 12 and 24 months
    • To investigate the influence of endovascular denervation on glucagon.
  • Changes in blood pressure up to 2 years
    • Time Frame: 3, 6, 12 and 24 months
    • To investigate the influence of endovascular denervation on blood pressure.
  • Changes in creatinine up to 2 years
    • Time Frame: 3, 6, 12 and 24 months
    • To investigate the influence of endovascular denervation on creatinine.
  • Changes in blood urea nitrogen (BUN) up to 2 years
    • Time Frame: 3, 6, 12 and 24 months
    • To investigate the influence of endovascular denervation on BUN.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhongda Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gao-jun Teng, President – Zhongda Hospital
  • Overall Contact(s)
    • Gao-Jun Teng,, MD, +86 25 83272121, gjteng@seu.edu.cn

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