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Type 2 Diabetes Mellitus (T2DM)NCT05673668

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

A study testing Endovascular Denervation System (Netrod) in people with Type 2 Diabetes Mellitus (T2DM), run by Zhongda Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) . Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Endovascular Denervation System (Netrod)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
27 Dec 2022to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)
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  • 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

Trial locations and contacts

1 site in 1 country.

Zhi Wang, MD contact

+8618652918783

wangzhiseu@163.com

China1 site, 1 recruiting

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

    Gaojun Teng, MD

    Recruiting

Other trials in China

About this study

Official title: Clinical Mechanism of Endovascular Denervation (EDN) for the Treatment of Type 2 Diabetes

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) .

Read the detailed description

This is a prospective, single-center, single-arm, self-controlled study. Patients with diagnosed T2DM and poor glycemic control (i.e.. glycated hemoglobin A1c (HbA1c) between 7.5% and 10.5% despite one to three oral antidiabetic drugs (OAD) and/or insulin on the basis of metformin. All included subjects will accept EDN treatment and were followed up at 7, 30 days and 3, 6, 12 months. The primary objectives were evaluate the effects of EDN on insulin secretory function and insulin sensitivity in the treatment of T2DM.

Being tested
Endovascular Denervation System (Netrod)
Keywords
Type 2 Diabetes Mellitus, Endovascular denervation
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05673668
Study groupRoleWhat they receive
The endovascular denervation (EDN) groupExperimentalReceive endovascular denervation (EDN) treatment
Receives: Device: Endovascular Denervation System (Netrod)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of islet secretory function (HOMA-β)

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

    Measured: From baseline to 6 months

Secondary outcomes (15)

  1. Incidence of device or procedure-related major adverse events

    Incidence of device or procedure-related major adverse events from baseline to 12 months post procedure

    Measured: From baseline to 12 months post procedure

  2. Changes in Hba1c

    Changes in Hba1c from baseline at 12 months post procedure

    Measured: From baseline to 12 months post procedure

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

    Changes in the time in range (TIR) over 14 days of using continuous glucose monitoring at 12 months post procedure

    Measured: From baseline to 12 months post procedure

  4. Changes in the area under OGTT insulin release curve

    Change in the area under OGTT insulin release curve from base line to 12 months post procedure

    Measured: From baseline to 12 months post procedure

  5. Changes in the area under OGTT C-peptide release curve

    Changes in the area under OGTT C-peptide release curve from base line to 12 months post procedure

    Measured: From baseline to 12 months post procedure

  6. Changes in liver fat content

    Changes in liver fat content from baseline at 6 months post procedure

    Measured: From baseline to 6 months post procedure

  7. Changes in liver function

    Changes of liver function (ALT, AST, GGT, ALP) from baseline at 6 months post procedure

    Measured: From baseline to 6 months post procedure

  8. Changes in blood lipids

    Changes in blood lipid as indicated by triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol from baseline at 12 months post procedure

    Measured: From baseline to 12 months post procedure

  9. Changes in the gastric emptying

    Changes in the gastric emptying as indicated by 13C-acetate breath test from baseline at 12 months post procedure

    Measured: From baseline to 12 months post procedure

  10. Changes in insulin sensitivity

    Changes in insulin sensitivity as indicated by glucose infusion rate and M value in hyperinsulinemic-euglycemic clamp from baseline at 6 months post procedure

    Measured: From baseline to 6 months post procedure

  11. Changes in metabolic-related hormones

    Changes in metabolic-related hormones including glucagon, pancreatic polypeptide, glucagon-like peptide-1, gastric inhibitory polypeptide, neuropeptide Y, peptide YY, ghrelin, adiponectin and leptin

    Measured: From baseline to 6 months post procedure

  12. Changes in plasma cytokines

    Changes in plasma cytokines including IFN-γ、IL-1β、IL-2、IL-4、IL-6、IL-10、IL-12p70、IL-17A、TNF-α、IL-13、IL-15、MCP-1、FGF21/23 and BDNF from baseline at 6 months post procedure

    Measured: From baseline to 6 months post procedure

  13. Changes in blood and fecal metabolome

    Changes in blood and fecal metabolome (Using liquid-mass combination (LC - MS) method) from baseline at 6 months post procedure

    Measured: From baseline to 6 months post procedure

  14. Changes in fecal microbiota

    Changes in fecal microbiota (Using liquid-mass combination (LC - MS) method assess fecal 16S-rRNA sequencing and non-targeted metabolomics) from baseline at 6 months post procedure

    Measured: From baseline to 6 months post procedure

  15. Change of sympathetic nervous system activity

    Change of sympathetic nervous system activity (cardiac strain capacity was evaluated by autonomic nervous function and Cardiopulmonary resonance assesses sympathetic nervous system excitability) from baseline at 6 months post procedure

    Measured: From baseline to 6 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start27 Dec 2022
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673668
Sponsor's protocol ID
EDN-T2DM
Status last verified
Jul 2023
First submitted
28 Nov 2022
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular Denervation System (Netrod) in people with Type 2 Diabetes Mellitus (T2DM), run by Zhongda Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhi Wang, MD (+8618652918783, wangzhiseu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of islet secretory function (HOMA-β) (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.

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