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Renal Denervation in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03418415
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
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 we assume that renal denervation (RDN) might improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based RDN on glucose metabolism and insulin sensitivity in patients with T2DM.

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

Detailed Description:
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that renal denervation (RDN) 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 RDN, and fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. But in some clinical studies, RDN did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after RDN. Therefore, the efficacy of RDN on glucose metabolism is still in controversy. The investigators wish to investigate the effect of multi-electrode catheter-based RDN on glucose metabolism and insulin sensitivity in patients with T2DM.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Renal denervation
Procedure: Renal denervation
Device: Renal denervation
multi-electrode catheter-based renal denervation




Primary Outcome Measures :
  1. Changes in glucose metabolism from baseline to 6 months [ Time Frame: 6 months ]
    To investigate the influence of RDN on glucose metabolism. Hereby evaluating Oral Glucose Tolerance Test (OGTT) and glycosylated hemoglobin (HbA1c) before and after RDN.


Secondary Outcome Measures :
  1. Changes in glucose metabolism up to 2 years [ Time Frame: 3, 12 and 24 months ]
    To investigate the influence of RDN on glucose metabolism. Hereby evaluating Oral Glucose Tolerance Test (OGTT) and glycosylated hemoglobin (HbA1c) before and after RDN.

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

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

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

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

  6. Changes in triglyceride and high density lipoprotein (HDL) up to 2 years [ Time Frame: 3, 6, 12 and 24 months ]
    To investigate the influence of RDN on triglyceride and HDL.

  7. Changes in renal function up to 2 years [ Time Frame: 3, 6, 12 and 24 months ]
    To investigate the influence of RDN on creatinine and blood urea nitrogen (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:

  • Renal arterial anatomy ineligible for RDN: main renal arteries <4 mm in diameter or <20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply <75% of the kidney
  • 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): NCT03418415


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

Locations
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   
Sponsors and Collaborators
Zhongda Hospital
Investigators
Principal Investigator: Gao-Jun Teng, MD Zhongda Hospital, Southeast University

Responsible Party: Gao-jun Teng, Clinical Professor, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT03418415     History of Changes
Other Study ID Numbers: 2018RDN-T2DM
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases