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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Netrod system is a percutaneous, catheter- based device which uses radiofrequency energy to denervate the sympathetic nerves surrounding the arteries
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
RECRUITINGChanges of islet secretory function (HOMA-β)
Changes of islet secretory function (HOMA-β, HOMA-IR) from baseline at 6 months post procedure
Time frame: From baseline to 6 months
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
Time frame: From baseline to 12 months post procedure
Changes in Hba1c
Changes in Hba1c from baseline at 12 months post procedure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to 12 months post procedure
Changes in liver fat content
Changes in liver fat content from baseline at 6 months post procedure
Time frame: From baseline to 6 months post procedure
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Changes in liver function
Changes of liver function (ALT, AST, GGT, ALP) from baseline at 6 months post procedure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to 6 months post procedure