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The MILESTONE Study

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ClinicalTrials.gov Identifier: NCT04086043
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, Zhongda Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Endovascular Denervation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study
Estimated Study Start Date : September 10, 2019
Estimated Primary Completion Date : September 9, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endovascular Denervation Device: Endovascular Denervation
multi-electrode catheter-based endovascular denervation




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. 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).

  2. 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. Changes in insulin up to 2 years [ Time Frame: 3, 6, 12 and 24 months ]
    To investigate the influence of endovascular denervation on insulin.

  4. Changes in catecholamine up to 2 years [ Time Frame: 3, 6, 12 and 24 months ]
    To investigate the influence of endovascular denervation on catecholamine.

  5. Changes in glucagon up to 2 years [ Time Frame: 3, 6, 12 and 24 months ]
    To investigate the influence of endovascular denervation on glucagon.

  6. 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.

  7. Changes in creatinine up to 2 years [ Time Frame: 3, 6, 12 and 24 months ]
    To investigate the influence of endovascular denervation on creatinine.

  8. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086043


Contacts
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Contact: Gao-Jun Teng,, MD +86 25 83272121 gjteng@seu.edu.cn
Contact: Tao Pan, PhD +86-15850651223 15850651223@126.com

Locations
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China, Jiangsu
Zhongda Hospital, Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Gao-Jun Teng, MD    +86 25 83272121    gjteng@seu.edu.cn   
Contact: Tao Pan, PhD    +86-15850651223    15850651223@126.com   
Principal Investigator: Gao-Jun Teng, MD         
Sponsors and Collaborators
Zhongda Hospital

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Responsible Party: Gao-jun Teng, President, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT04086043     History of Changes
Other Study ID Numbers: EDNT2DM-2019
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases