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This is a prospective, single-center, single-arm, self-controlled study to evaluate the effects of endovascular denervation (EDN) on insulin secretory function and insulin sensitivity in the treatment of type 2 diabetes mellitus (T2DM) .
This is a prospective, single-center, single-arm, self-controlled study. Patients with diagnosed T2DM and poor glycemic control (i.e.. glycated hemoglobin A1c (HbA1c) between 7.5% and 10.5% despite one to three oral antidiabetic drugs (OAD) and/or insulin on the basis of metformin. All included subjects will accept EDN treatment and were followed up at 7, 30 days and 3, 6, 12 months. The primary objectives were evaluate the effects of EDN on insulin secretory function and insulin sensitivity in the treatment of T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The endovascular denervation (EDN) group | Experimental | Receive endovascular denervation (EDN) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Denervation System (Netrod) | Device | The Netrod system is a percutaneous, catheter- based device which uses radiofrequency energy to denervate the sympathetic nerves surrounding the arteries |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of islet secretory function (HOMA-β) | Changes of islet secretory function (HOMA-β, HOMA-IR) from baseline at 6 months post procedure | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device or procedure-related major adverse events | Incidence of device or procedure-related major adverse events from baseline to 12 months post procedure | From baseline to 12 months post procedure |
| Changes in Hba1c |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Wang, MD | Contact | +8618652918783 | wangzhiseu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gaojun 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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Changes in Hba1c from baseline at 12 months post procedure
| From baseline to 12 months post procedure |
| Changes in the time in range (TIR) over 14 days of glucose | Changes in the time in range (TIR) over 14 days of using continuous glucose monitoring at 12 months post procedure | From baseline to 12 months post procedure |
| Changes in the area under OGTT insulin release curve | Change in the area under OGTT insulin release curve from base line to 12 months post procedure | From baseline to 12 months post procedure |
| Changes in the area under OGTT C-peptide release curve | Changes in the area under OGTT C-peptide release curve from base line to 12 months post procedure | From baseline to 12 months post procedure |
| Changes in liver fat content | Changes in liver fat content from baseline at 6 months post procedure | From baseline to 6 months post procedure |
| Changes in liver function | Changes of liver function (ALT, AST, GGT, ALP) from baseline at 6 months post procedure | From baseline to 6 months post procedure |
| Changes in blood lipids | Changes in blood lipid as indicated by triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol from baseline at 12 months post procedure | From baseline to 12 months post procedure |
| Changes in the gastric emptying | Changes in the gastric emptying as indicated by 13C-acetate breath test from baseline at 12 months post procedure | From baseline to 12 months post procedure |
| Changes in insulin sensitivity | Changes in insulin sensitivity as indicated by glucose infusion rate and M value in hyperinsulinemic-euglycemic clamp from baseline at 6 months post procedure | From baseline to 6 months post procedure |
| Changes in metabolic-related hormones | Changes in metabolic-related hormones including glucagon, pancreatic polypeptide, glucagon-like peptide-1, gastric inhibitory polypeptide, neuropeptide Y, peptide YY, ghrelin, adiponectin and leptin | From baseline to 6 months post procedure |
| Changes in plasma cytokines | Changes in plasma cytokines including IFN-γ、IL-1β、IL-2、IL-4、IL-6、IL-10、IL-12p70、IL-17A、TNF-α、IL-13、IL-15、MCP-1、FGF21/23 and BDNF from baseline at 6 months post procedure | From baseline to 6 months post procedure |
| Changes in blood and fecal metabolome | Changes in blood and fecal metabolome (Using liquid-mass combination (LC - MS) method) from baseline at 6 months post procedure | From baseline to 6 months post procedure |
| Changes in fecal microbiota | Changes in fecal microbiota (Using liquid-mass combination (LC - MS) method assess fecal 16S-rRNA sequencing and non-targeted metabolomics) from baseline at 6 months post procedure | From baseline to 6 months post procedure |
| Change of sympathetic nervous system activity | Change of sympathetic nervous system activity (cardiac strain capacity was evaluated by autonomic nervous function and Cardiopulmonary resonance assesses sympathetic nervous system excitability) from baseline at 6 months post procedure | From baseline to 6 months post procedure |
| D004700 | Endocrine System Diseases |