Back to resultsRenal Denervation in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus, Renal Denervation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Renal denervation
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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:
- 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
Sites / Locations
- Zhongda Hospital, Southeast UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renal denervation
Arm Description
Procedure: Renal denervation
Outcomes
Primary Outcome Measures
Changes in glucose metabolism from baseline to 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
Changes in glucose metabolism up to 2 years
To investigate the influence of RDN on glucose metabolism. Hereby evaluating Oral Glucose Tolerance Test (OGTT) and glycosylated hemoglobin (HbA1c) before and after RDN.
Changes in insulin and C-peptide up to 2 years
To investigate the influence of RDN on insulin and C-peptide.
Changes in catecholamine up to 2 years
To investigate the influence of RDN on catecholamine.
Changes in glucagon up to 2 years
To investigate the influence of RDN on glucagon.
Changes in blood pressure up to 2 years
To investigate the influence of RDN on blood pressure.
Changes in triglyceride and high density lipoprotein (HDL) up to 2 years
To investigate the influence of RDN on triglyceride and HDL.
Changes in renal function up to 2 years
To investigate the influence of RDN on creatinine and blood urea nitrogen (BUN).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03418415
Brief Title
Renal Denervation in Patients With Type 2 Diabetes Mellitus
Official Title
Renal Denervation in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 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
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Renal Denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renal denervation
Arm Type
Experimental
Arm Description
Procedure: Renal denervation
Intervention Type
Device
Intervention Name(s)
Renal denervation
Intervention Description
multi-electrode catheter-based renal denervation
Primary Outcome Measure Information:
Title
Changes in glucose metabolism from baseline to 6 months
Description
To investigate the influence of RDN on glucose metabolism. Hereby evaluating Oral Glucose Tolerance Test (OGTT) and glycosylated hemoglobin (HbA1c) before and after RDN.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in glucose metabolism up to 2 years
Description
To investigate the influence of RDN on glucose metabolism. Hereby evaluating Oral Glucose Tolerance Test (OGTT) and glycosylated hemoglobin (HbA1c) before and after RDN.
Time Frame
3, 12 and 24 months
Title
Changes in insulin and C-peptide up to 2 years
Description
To investigate the influence of RDN on insulin and C-peptide.
Time Frame
3, 6, 12 and 24 months
Title
Changes in catecholamine up to 2 years
Description
To investigate the influence of RDN on catecholamine.
Time Frame
3, 6, 12 and 24 months
Title
Changes in glucagon up to 2 years
Description
To investigate the influence of RDN 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 RDN on blood pressure.
Time Frame
3, 6, 12 and 24 months
Title
Changes in triglyceride and high density lipoprotein (HDL) up to 2 years
Description
To investigate the influence of RDN on triglyceride and HDL.
Time Frame
3, 6, 12 and 24 months
Title
Changes in renal function up to 2 years
Description
To investigate the influence of RDN on creatinine and blood urea nitrogen (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:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Renal Denervation in Patients With Type 2 Diabetes Mellitus
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