The MILESTONE Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086043
• Other study ID #: EDNT2DM-2019
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2019
• Source: Zhongda Hospital
• Contact: Gao-Jun Teng,, MD
• Phone: +86 25 83272121
• Email: gjteng[@]seu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in glycosylated hemoglobin from baseline to 6 months	To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).	6 months
Secondary	Changes in Oral Glucose Tolerance Test up to 2 years	To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).	3, 12 and 24 months
Secondary	Changes in glycosylated hemoglobin up to 2 years	To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).	3, 12 and 24 months
Secondary	Changes in insulin up to 2 years	To investigate the influence of endovascular denervation on insulin.	3, 6, 12 and 24 months
Secondary	Changes in catecholamine up to 2 years	To investigate the influence of endovascular denervation on catecholamine.	3, 6, 12 and 24 months
Secondary	Changes in glucagon up to 2 years	To investigate the influence of endovascular denervation on glucagon.	3, 6, 12 and 24 months
Secondary	Changes in blood pressure up to 2 years	To investigate the influence of endovascular denervation on blood pressure.	3, 6, 12 and 24 months
Secondary	Changes in creatinine up to 2 years	To investigate the influence of endovascular denervation on creatinine.	3, 6, 12 and 24 months
Secondary	Changes in blood urea nitrogen (BUN) up to 2 years	To investigate the influence of endovascular denervation on BUN.	3, 6, 12 and 24 months