NCT03418415

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 25, 2018

Last Update Submit

January 25, 2018

Conditions

Type 2 Diabetes MellitusRenal Denervation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Changes in glucose metabolism up to 2 years

    3, 12 and 24 months

  • Changes in insulin and C-peptide up to 2 years

    3, 6, 12 and 24 months

  • Changes in catecholamine up to 2 years

    3, 6, 12 and 24 months

  • Changes in glucagon up to 2 years

    3, 6, 12 and 24 months

  • Changes in blood pressure up to 2 years

    3, 6, 12 and 24 months

  • +2 more secondary outcomes

Study Arms (1)

Renal denervation

EXPERIMENTAL

Procedure: Renal denervation

Device: Renal denervation

Interventions

Renal denervationDEVICE

multi-electrode catheter-based renal denervation

Renal denervation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gao-Jun Teng, MD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, MD

CONTACT

+86 25 83272121gjteng@seu.edu.cn

Tao Pan, PhD

CONTACT

+86-1585065122315850651223@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 1, 2018

Study Start

January 18, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2022

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)