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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Denervation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Denervation | Device | multi-electrode catheter-based endovascular denervation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Oral Glucose Tolerance Test from baseline to 6 months | To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT). | 6 months |
| Changes in glycosylated hemoglobin from baseline to 6 months | To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Oral Glucose Tolerance Test up to 2 years | To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT). | 3, 12 and 24 months |
| Changes in glycosylated hemoglobin 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 |
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| 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 endovascular denervation on glycosylated hemoglobin (HbA1c).
| 3, 12 and 24 months |
| Changes in insulin up to 2 years | To investigate the influence of endovascular denervation on insulin. | 3, 6, 12 and 24 months |
| Changes in catecholamine up to 2 years | To investigate the influence of endovascular denervation on catecholamine. | 3, 6, 12 and 24 months |
| Changes in glucagon up to 2 years | To investigate the influence of endovascular denervation on glucagon. | 3, 6, 12 and 24 months |
| Changes in blood pressure up to 2 years | To investigate the influence of endovascular denervation on blood pressure. | 3, 6, 12 and 24 months |
| Changes in creatinine up to 2 years | To investigate the influence of endovascular denervation on creatinine. | 3, 6, 12 and 24 months |
| Changes in blood urea nitrogen (BUN) up to 2 years | To investigate the influence of endovascular denervation on BUN. | 3, 6, 12 and 24 months |
| D004700 | Endocrine System Diseases |