The MILESTONE Study

September 10, 2019 updated by: Gao-jun Teng, Zhongda Hospital

MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital, Southeast University
        • Contact:
        • Principal Investigator:
          • Gao-Jun Teng, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular Denervation
Device: Endovascular Denervation
multi-electrode catheter-based endovascular denervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
Changes in glycosylated hemoglobin from baseline to 6 months
Time Frame: 6 months
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3, 12 and 24 months
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).
3, 12 and 24 months
Changes in insulin up to 2 years
Time Frame: 3, 6, 12 and 24 months
To investigate the influence of endovascular denervation on insulin.
3, 6, 12 and 24 months
Changes in catecholamine up to 2 years
Time Frame: 3, 6, 12 and 24 months
To investigate the influence of endovascular denervation on catecholamine.
3, 6, 12 and 24 months
Changes in glucagon up to 2 years
Time Frame: 3, 6, 12 and 24 months
To investigate the influence of endovascular denervation on glucagon.
3, 6, 12 and 24 months
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.
3, 6, 12 and 24 months
Changes in creatinine up to 2 years
Time Frame: 3, 6, 12 and 24 months
To investigate the influence of endovascular denervation on creatinine.
3, 6, 12 and 24 months
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.
3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 10, 2019

Primary Completion (Anticipated)

September 9, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDNT2DM-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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