Renal Denervation in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Renal Denervation in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus, Renal Denervation

Intervention / Treatment
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* Device: Renal denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation<br>Procedure: Renal denervation | Device: Renal denervation<br>* multi-electrode catheter-based renal denervation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3, 12 and 24 months | 
| Changes in insulin and C-peptide up to 2 years | To investigate the influence of RDN on insulin and C-peptide. | 3, 6, 12 and 24 months | 
| Changes in catecholamine up to 2 years | To investigate the influence of RDN on catecholamine. | 3, 6, 12 and 24 months | 
| Changes in glucagon up to 2 years | To investigate the influence of RDN on glucagon. | 3, 6, 12 and 24 months | 
| Changes in blood pressure up to 2 years | To investigate the influence of RDN on blood pressure. | 3, 6, 12 and 24 months | 
| Changes in triglyceride and high density lipoprotein (HDL) up to 2 years | To investigate the influence of RDN on triglyceride and HDL. | 3, 6, 12 and 24 months | 
| Changes in renal function up to 2 years | To investigate the influence of RDN on creatinine and blood urea nitrogen (BUN). | 3, 6, 12 and 24 months |