Renal Denervation in Patients With Type 2 Diabetes Mellitus

Not Applicable

• Conditions: Renal Denervation; Type 2 Diabetes Mellitus
• Interventions: Device: Renal denervation

• Registration Number: NCT03418415
• Lead Sponsor: Zhongda Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-18
• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-02-01
• Last Update Posted: 2018-02-01
• Primary Completion: 2020-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Over 18 years and ≤ 70 years old
• Able and willing to provide informed consent
• Patients with established type II diabetes mellitus (HbA1C>7.5%, diet or oral hypoglycaemic agents)
• Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
• Anticipated that patients are able to maintain a stable dose of medication for the duration of the study

Exclusion Criteria

• Renal arterial anatomy ineligible for RDN: main renal arteries <4 mm in diameter or <20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply <75% of the kidney
• History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation
• Type 1 diabetes mellitus
• Pregnant, nursing or planning to be pregnant
• Orthostatic hypotension
• eGFR <30 ml/min (MDRD formula)
• Patients that have allergy to contrast agent
• Myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
• Cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion
• Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation	Renal denervation	Procedure: Renal denervation

Primary Outcome Measures

Name	Time	Method
Changes in glucose metabolism from baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in insulin and C-peptide up to 2 years	3, 6, 12 and 24 months	To investigate the influence of RDN on insulin and C-peptide.
Changes in renal function up to 2 years	3, 6, 12 and 24 months	To investigate the influence of RDN on creatinine and blood urea nitrogen (BUN).
Changes in glucose metabolism up to 2 years	3, 12 and 24 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.
Changes in catecholamine up to 2 years	3, 6, 12 and 24 months	To investigate the influence of RDN on catecholamine.
Changes in blood pressure up to 2 years	3, 6, 12 and 24 months	To investigate the influence of RDN on blood pressure.
Changes in glucagon up to 2 years	3, 6, 12 and 24 months	To investigate the influence of RDN on glucagon.
Changes in triglyceride and high density lipoprotein (HDL) up to 2 years	3, 6, 12 and 24 months	To investigate the influence of RDN on triglyceride and HDL.

Trial Locations

Locations (1)

Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China