An interventional study of Renal denervation in Type 2 Diabetes Mellitus and Renal Denervation, sponsored by Zhongda Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-01.
Sponsored by Zhongda Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Procedure: Renal denervation
Device: Renal denervation
multi-electrode catheter-based renal denervation
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 3, 6, 12 and 24 months
Changes in catecholamine up to 2 years
To investigate the influence of RDN on catecholamine.
Time frame: 3, 6, 12 and 24 months
Changes in glucagon up to 2 years
To investigate the influence of RDN on glucagon.
Time frame: 3, 6, 12 and 24 months
Changes in blood pressure up to 2 years
To investigate the influence of RDN on blood pressure.
Time frame: 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.
Time frame: 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).
Time frame: 3, 6, 12 and 24 months
Plan to share: No
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Zhongda Hospital