Renal Denervation in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Renal Denervation in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03418415
• Other study ID #: 2018RDN-T2DM
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2018
• Last updated: January 25, 2018
• Start date: January 18, 2018
• Est. completion date: January 2022

Study information

• Verified date: January 2018
• Source: Zhongda Hospital
• Contact: Gao-Jun Teng, MD
• Phone: +86 25 83272121
• Email: gjteng[@]seu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2022
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Denervation
• Type 2 Diabetes Mellitus

Intervention

Device:
• Renal denervation
multi-electrode catheter-based renal denervation

Locations

Country	Name	City	State
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	3, 12 and 24 months
Secondary	Changes in insulin and C-peptide up to 2 years	To investigate the influence of RDN on insulin and C-peptide.	3, 6, 12 and 24 months
Secondary	Changes in catecholamine up to 2 years	To investigate the influence of RDN on catecholamine.	3, 6, 12 and 24 months
Secondary	Changes in glucagon up to 2 years	To investigate the influence of RDN on glucagon.	3, 6, 12 and 24 months
Secondary	Changes in blood pressure up to 2 years	To investigate the influence of RDN on blood pressure.	3, 6, 12 and 24 months
Secondary	Changes in triglyceride and high density lipoprotein (HDL) up to 2 years	To investigate the influence of RDN on triglyceride and HDL.	3, 6, 12 and 24 months
Secondary	Changes in renal function up to 2 years	To investigate the influence of RDN on creatinine and blood urea nitrogen (BUN).	3, 6, 12 and 24 months