Renal Denervation in Patients With Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Metabolic and Cardiovascular Effects of Renal Denervation

NCT02057224

Insulin Resistance Hypertension

TERMINATED NA

The Effects of Renal Denervation on Insulin Sensitivity

NCT01631370

Treatment Resistant Essential Hypertension Insulin Resistance

COMPLETED NA

Renal Denervation in Diabetes.

NCT02081989

Diabetes

WITHDRAWN PHASE4

Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

NCT04625751

Type 2 Diabetes Cardiovascular Autonomic Neuropathy

ACTIVE_NOT_RECRUITING

Validation of Biomarkers of Diabetic Nephropathy in Type I Diabetic Children

NCT02164279

Type 1 Diabetes Mellitus With Diabetic Nephropathy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus Renal Denervation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Renal denervation

Procedure: Renal denervation

Group Type EXPERIMENTAL

Renal denervation

Intervention Type DEVICE

multi-electrode catheter-based renal denervation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Renal denervation

multi-electrode catheter-based renal denervation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No