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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation | Experimental | Procedure: Renal denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation | Device | multi-electrode catheter-based renal denervation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao-Jun Teng, MD | Contact | +86 25 83272121 | gjteng@seu.edu.cn | |
| Tao Pan, PhD | Contact | +86-15850651223 | 15850651223@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| D004700 | Endocrine System Diseases |