The MILESTONE Study

NCT04086043 | Unknown DMC

• 1 other identifier: EDNT2DM-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Changes in Oral Glucose Tolerance Test from baseline to 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

  To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).

  6 months

Secondary Outcomes (8)

• Changes in Oral Glucose Tolerance Test up to 2 years

  3, 12 and 24 months

• Changes in glycosylated hemoglobin up to 2 years

  3, 12 and 24 months

• Changes in insulin up to 2 years

  3, 6, 12 and 24 months

• Changes in catecholamine up to 2 years

  3, 6, 12 and 24 months

• Changes in glucagon up to 2 years

  3, 6, 12 and 24 months

Study Arms (1)

Endovascular Denervation

EXPERIMENTAL

Device: Endovascular Denervation

Interventions

Endovascular Denervation DEVICE

multi-electrode catheter-based endovascular denervation

Endovascular Denervation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Gao-Jun Teng,, MD

CONTACT

+86 25 83272121; gjteng@seu.edu.cn

Tao Pan, PhD

CONTACT

+86-15850651223; 15850651223@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 11, 2019
• Study Start: September 10, 2019
• Primary Completion: September 9, 2022
• Study Completion: December 31, 2022
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)