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The MILESTONE Study

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endovascular Denervation
Sponsored by
Zhongda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongda Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Denervation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in Oral Glucose Tolerance Test up to 2 years
To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
Changes in glycosylated hemoglobin up to 2 years
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
Changes in insulin up to 2 years
To investigate the influence of endovascular denervation on insulin.
Changes in catecholamine up to 2 years
To investigate the influence of endovascular denervation on catecholamine.
Changes in glucagon up to 2 years
To investigate the influence of endovascular denervation on glucagon.
Changes in blood pressure up to 2 years
To investigate the influence of endovascular denervation on blood pressure.
Changes in creatinine up to 2 years
To investigate the influence of endovascular denervation on creatinine.
Changes in blood urea nitrogen (BUN) up to 2 years
To investigate the influence of endovascular denervation on BUN.

Full Information

First Posted
September 5, 2019
Last Updated
September 10, 2019
Sponsor
Zhongda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04086043
Brief Title
The MILESTONE Study
Official Title
MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2019 (Anticipated)
Primary Completion Date
September 9, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular Denervation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endovascular Denervation
Intervention Description
multi-electrode catheter-based endovascular denervation
Primary Outcome Measure Information:
Title
Changes in Oral Glucose Tolerance Test from baseline to 6 months
Description
To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
Time Frame
6 months
Title
Changes in glycosylated hemoglobin from baseline to 6 months
Description
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in Oral Glucose Tolerance Test up to 2 years
Description
To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
Time Frame
3, 12 and 24 months
Title
Changes in glycosylated hemoglobin up to 2 years
Description
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
Time Frame
3, 12 and 24 months
Title
Changes in insulin up to 2 years
Description
To investigate the influence of endovascular denervation on insulin.
Time Frame
3, 6, 12 and 24 months
Title
Changes in catecholamine up to 2 years
Description
To investigate the influence of endovascular denervation on catecholamine.
Time Frame
3, 6, 12 and 24 months
Title
Changes in glucagon up to 2 years
Description
To investigate the influence of endovascular denervation on glucagon.
Time Frame
3, 6, 12 and 24 months
Title
Changes in blood pressure up to 2 years
Description
To investigate the influence of endovascular denervation on blood pressure.
Time Frame
3, 6, 12 and 24 months
Title
Changes in creatinine up to 2 years
Description
To investigate the influence of endovascular denervation on creatinine.
Time Frame
3, 6, 12 and 24 months
Title
Changes in blood urea nitrogen (BUN) up to 2 years
Description
To investigate the influence of endovascular denervation on BUN.
Time Frame
3, 6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao-Jun Teng,, MD
Phone
+86 25 83272121
Email
gjteng@seu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Pan, PhD
Phone
+86-15850651223
Email
15850651223@126.com
Facility Information:
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Phone
+86 25 83272121
Email
gjteng@seu.edu.cn
First Name & Middle Initial & Last Name & Degree
Tao Pan, PhD
Phone
+86-15850651223
Email
15850651223@126.com
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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