Endovascular Denervation (EDN) for the Treatment of Type 2 Diabetes Mellitus

NCT05673668 | Unknown

• 1 other identifier: EDN-T2DM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, single-arm, self-controlled study to evaluate the effects of endovascular denervation (EDN) on insulin secretory function and insulin sensitivity in the treatment of type 2 diabetes mellitus (T2DM) .

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes Mellitus; Endovascular denervation

Outcome Measures

Primary Outcomes (1)

• Changes of islet secretory function (HOMA-β)

  Changes of islet secretory function (HOMA-β, HOMA-IR) from baseline at 6 months post procedure

  From baseline to 6 months

Secondary Outcomes (15)

• Incidence of device or procedure-related major adverse events

  From baseline to 12 months post procedure

• Changes in Hba1c

  From baseline to 12 months post procedure

• Changes in the time in range (TIR) over 14 days of glucose

  From baseline to 12 months post procedure

• Changes in the area under OGTT insulin release curve

  From baseline to 12 months post procedure

• Changes in the area under OGTT C-peptide release curve

  From baseline to 12 months post procedure

Study Arms (1)

The endovascular denervation (EDN) group

EXPERIMENTAL

Receive endovascular denervation (EDN) treatment

Device: Endovascular Denervation System (Netrod)

Interventions

Endovascular Denervation System (Netrod) DEVICE

The Netrod system is a percutaneous, catheter- based device which uses radiofrequency energy to denervate the sympathetic nerves surrounding the arteries

The endovascular denervation (EDN) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with age of #18 years old and#75 years old (both ends included)
• Subject (or legal guardian) understands the requirements and treatment of this clinical trial and agrees to and is able to complete the trial
• Diagnosed with T2DM for ≤15 years (according to WHO criteria)
• On the basis of metformin (daily dose ≥1000mg), using a combination of 1-3 OADs for more than last 3 months, with or without insulin (dose not limited). Defined OADs were: sulfonylureas/ glienides, thiazolidinediones and α-glycosidase inhibitors
• Glycosylated hemoglobin (HbA1c) levels between 7.5% and 10.5% (based on baseline tests)
• Body mass index (BMI) ≥ 18 and ≤40kg/m2

You may not qualify if:

• T1DM or any secondary diabetes
• History of aortic disease (such as aortic aneurysm or aortic dissection) or aortic surgery (including celiac artery dissection)
• Baseline CTA examination revealed aortic aneurysm or aortic dissection, or abnormal anatomical structure of hepatic artery and its branches, or other vascular structure/status abnormalities (such as severe tortuosity or narrowing of the artery, endovascular thrombosis or unstable plaque, etc.) that were not suitable for endovascular denervation as determined by the researcher
• More than 2 self-reported or documented events of severe hypoglycemia (defined as hypoglycemia with severe cognitive impairment requiring assistance) within the past 6 months
• Patients who had a major cardiovascular and cerebrovascular event (MACCE), major surgery, severe infection, gastrointestinal bleeding, and acute pancreatitis in the past 6 months
• Severe autonomic neuropathy (postural hypotension, etc.)
• Severe liver insufficiency (ALT and/or AST above 3 times the normal upper limit or serum total bilirubin above 2 times the normal upper limit), renal insufficiency (eGFR \< 60mL/ min/1.73m2). eGFR calculation formula is shown in Note e of Table 4.3 Data collection table.), chronic pancreatitis, cocoagulation disorder (PT, APTT or INR higher than 2 times of the normal upper limit; Platelet count \< 80×109/L or ≥ 700×109/L) and malignant tumors
• Suffering from mental illness and unable to cooperate
• Pregnant
• There were conditions that the researchers determined will affect the safety of the subjects or interfere with the evaluation of the test results
• Patients not eligible for MRI (e.g. paramagnetic metal implants, claustrophobia, etc.)
• Participating in or currently participating in other clinical studies within 3 months prior to enrollment

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gaojun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Wang, MD

CONTACT

+8618652918783; wangzhiseu@163.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: November 28, 2022
• First Posted: January 6, 2023
• Study Start: December 27, 2022
• Primary Completion: October 30, 2023
• Study Completion: April 30, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

CN (1)