Type 2 Diabetes MellitusNCT04086043
The MILESTONE Study
A study testing Endovascular Denervation in people with Type 2 Diabetes Mellitus, run by Zhongda Hospital at 1 site in China.
Trial summary
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might reduce sympathetic overactivity and improve glucose metabolism and insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Endovascular Denervation
- 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
- 10 Sep 2019to 31 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Arterial anatomy ineligible for endovascular denervation
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Gao-Jun Teng, MD, +86 25 83272121, gjteng@seu.edu.cn
Tao Pan, PhD, +86-15850651223, 15850651223@126.com
About this study
Official title: MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might reduce sympathetic overactivity and improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
Read the detailed description
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation 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 denervation, and fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. But in some clinical studies, denervation did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after denervation. Therefore, the efficacy of denervation on glucose metabolism is still in controversy. The investigators wish to investigate the effect of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- 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 DenervationDevice
multi-electrode catheter-based endovascular denervation
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Denervation | Experimental | Not described Receives: Device: Endovascular Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Oral Glucose Tolerance Test from baseline to 6 months
To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
Measured: 6 months
Changes in glycosylated hemoglobin from baseline to 6 months
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
Measured: 6 months
Secondary outcomes (8)
Changes in Oral Glucose Tolerance Test up to 2 years
To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
Measured: 3, 12 and 24 months
Changes in glycosylated hemoglobin up to 2 years
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
Measured: 3, 12 and 24 months
Changes in insulin up to 2 years
To investigate the influence of endovascular denervation on insulin.
Measured: 3, 6, 12 and 24 months
Changes in catecholamine up to 2 years
To investigate the influence of endovascular denervation on catecholamine.
Measured: 3, 6, 12 and 24 months
Changes in glucagon up to 2 years
To investigate the influence of endovascular denervation on glucagon.
Measured: 3, 6, 12 and 24 months
Changes in blood pressure up to 2 years
To investigate the influence of endovascular denervation on blood pressure.
Measured: 3, 6, 12 and 24 months
Changes in creatinine up to 2 years
To investigate the influence of endovascular denervation on creatinine.
Measured: 3, 6, 12 and 24 months
Changes in blood urea nitrogen (BUN) up to 2 years
To investigate the influence of endovascular denervation on BUN.
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start10 Sep 2019 (estimated)
- Primary completion9 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086043
- Sponsor's protocol ID
- EDNT2DM-2019
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study
- ClinicalTrials.gov ID
- NCT04086043
- Acronym / sponsor ID
- EDNT2DM-2019
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 10 Sep 2019 (estimated)
- Primary completion
- 9 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might reduce sympathetic overactivity and improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
Detailed description
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation 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 denervation, and fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. But in some clinical studies, denervation did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after denervation. Therefore, the efficacy of denervation on glucose metabolism is still in controversy. The investigators wish to investigate the effect of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Denervation | Experimental | Device: Endovascular Denervation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Arterial anatomy ineligible for endovascular denervation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Denervationmulti-electrode catheter-based endovascular denervation | Device | Endovascular Denervation |
Primary outcome
Changes in Oral Glucose Tolerance Test from baseline to 6 months
Time frame: 6 months
To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
Changes in glycosylated hemoglobin from baseline to 6 months
Time frame: 6 months
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
8 secondary outcomes
Changes in Oral Glucose Tolerance Test up to 2 years
Time frame: 3, 12 and 24 months
Changes in glycosylated hemoglobin up to 2 years
Time frame: 3, 12 and 24 months
Changes in insulin up to 2 years
Time frame: 3, 6, 12 and 24 months
Changes in catecholamine up to 2 years
Time frame: 3, 6, 12 and 24 months
Changes in glucagon up to 2 years
Time frame: 3, 6, 12 and 24 months
Changes in blood pressure up to 2 years
Time frame: 3, 6, 12 and 24 months
Changes in creatinine up to 2 years
Time frame: 3, 6, 12 and 24 months
Changes in blood urea nitrogen (BUN) up to 2 years
Time frame: 3, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Denervation in people with Type 2 Diabetes Mellitus, 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 5 inclusion and 10 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 11 Sep 2019. 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 Gao-Jun Teng,, MD (+86 25 83272121, gjteng@seu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Oral Glucose Tolerance Test from baseline to 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2019.