Type 2 Diabetes Mellitus (T2DM)NCT07678866
A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control
An observational study of Type 2 Diabetes Mellitus (T2DM), run by Shanghai East Hospital at 1 site in China.
Trial summary
experiment design: Single-center, single-arm, open-label trial Inclusion Criteria: 1. Ages 18-70. 2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus. 3. The glycated hemoglobin level is 7.5%-10.5%. 4. BMI 2 7-40 kg/m2. 5. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: 1. Ages 18-70. 2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus. 3. The glycated hemoglobin level is 7.5%-10.5%. 4. BMI 2 7-40 kg/m2. 5. Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
Who may be able to join
- Ages 18-70.
- At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
- The glycated hemoglobin level is 7.5%-10.5%.
- BMI 2 7-40 kg/m2.
- Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
- Stable body weight (defined as a weight change of <5% within 5 weeks prior to screening)
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- Donation of blood is prohibited during the trial participation period.
- The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
- Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
- Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.
Who cannot join
- Diagnosed with type 1 diabetes mellitus.
- Severe diabetes-related complications such as diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- Fasting serum C-peptide <1 ng/mL (333 pmol/L).
- Over the past two years, insulin of any type has been used for more than 1 month (excluding treatment for gestational diabetes mellitus).
- History of ≥1 severe hypoglycemic episode within the past 6 months (defined as requiring assistance from a third party).
- Currently using a GLP-1RA or a dual GLP-6/GIP agonist.
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- Known autoimmune diseases.
- Previous gastrointestinal surgery that has altered the anatomical structure of the digestive tract or may limit duodenal resection, such as Billroth II, Roux-en-Y gastric bypass, gastric banding, or other similar procedures/diseases.
- A known history of upper gastrointestinal structural or functional disorders may impede device passage through the upper gastrointestinal tract or increase the risk of tissue injury during endoscopic procedures, including upper gastrointestinal strictures, esophageal-gastric varices, large diverticula, or other severe esophageal, gastric, or duodenal pathologies.
- History of gastroparesis.
- Acute gastrointestinal disease has occurred within the past 7 days.
- A history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel diseases such as Crohns disease and celiac disease is known.
- Previous history of chronic or acute pancreatitis.
- Active hepatitis or active liver disease, or an alanine aminotransferase (ALT) level>3.0 times the upper limit of normal (ULN) as determined by the central laboratory during screening evaluation.
- Currently, vitamin K antagonists such as warfarin are being used, or oral anticoagulants (DOCA) that cannot be safely discontinued are being administered.
- Patients currently using P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued within 7 days prior to surgery.
- Nonsteroidal anti-inflammatory drugs (NSAIDs) must not be discontinued within 4 weeks after treatment. Alternative use of acetaminophen and low-dose aspirin is permitted.
- Systemic glucocorticoids (excluding topical, ocular, or inhaled formulations) were administered continuously for more than 12 days within 10 weeks prior to screening.
- Use medications known to affect gastrointestinal motility
- Individuals currently using weight-loss medications or over-the-counter weight-loss drugs.
- Participate in any structured weight loss program or endoscopic weight loss intervention within 6 months after screening.
- Persistent anemia, defined as hemoglobin <10 g/dL.
- Known hemoglobinopathies, hemolytic anemia or sickle cell anemia, or other known hemoglobin abnormalities that may interfere with HbA1c measurement.
- A history of blood donation or transfusion within 3 months prior to screening.
- Unstable or paroxysmal arrhythmia.
- Any of the following cardiovascular diseases occurred within 6 months prior to screening: acute myocardial infarction (AMI), cerebrovascular accident (stroke), or hospitalization due to congestive heart failure.
- History of valvular heart disease or chronic heart failure (NYHA class III or IV).
- Individuals with known immunocompromised status, including but not limited to those who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, those with clinically significant leukopenia, those who are positive for human immunodeficiency virus (HIV), or whose immune status makes them unsuitable for clinical trial participation as determined by the investigators.
- There is secondary hypothyroidism or poorly controlled primary hypothyroidism (TSH levels exceed the normal range during screening).
- During the examination, do not implant any electronic devices that cannot be turned off (such as implantable cardiac pacemakers).
- A duodenal or biliary stent is in place.
- Patients with contraindications to upper gastrointestinal endoscopy or intravenous anesthesia.
- Currently diagnosed with malignant tumor or with a history of malignant tumor within the preceding 5 years (excluding non-melanoma skin cancer that has received adequate treatment with no evidence of recurrence at least 3 months prior to the study intervention, or treated cervical carcinoma in situ with no evidence of recurrence at least 3 months prior to the study intervention).
- Breastfeeding women.
- The participant is currently enrolled in another ongoing clinical trial.
- Binge eating disorder; a history or presence of severe, progressive, or uncontrolled renal, genitourinary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatic, neurological, psychiatric disorders, or metabolic disturbances; or any other psychological or physical condition deemed by the investigator to render the participant unsuitable for participation in the clinical trial.
- The patient is in critical condition or has an expected lifespan of less than 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East hospital
Shanghai
Lan Zhong, 86-13162099450, lanzhong@tongji.edu.cn
About this study
experiment design: Single-center, single-arm, open-label trial
Inclusion Criteria:
Read more
- Ages 18-70.
- At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
- The glycated hemoglobin level is 7.5%-10.5%.
- BMI 2 7-40 kg/m2.
- Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
- Stable body weight (defined as a weight change of <5% within 5 weeks prior to screening)
- Donation of blood is prohibited during the trial participation period.
- The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
- Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
- Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.
Primary efficacy endpoint :HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment Observation period: 6 months postoperatively. Secondary efficacy endpoint HbA1c: The difference in HbA1c levels from the baseline period to after treatment Observation periods: 1 month, 3 months, and 12 months post-treatment. Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Weight: Average weight from the baseline period to post-treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%.
Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Safety Indicator 1. Adverse Events and Serious Adverse Events 2. Device defect 3. Intraoperative Instrument Performance Evaluation
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- pulsed electric field ablation system, Type 2 Diabetes Mellitus (T2DM)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| The pulsed electric field ablation system in treating adult type 2 diabetes mellitus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment
Measured: Observation period: 6 months postoperatively.
Secondary outcomes (4)
HbA1c: The difference in HbA1c levels from the baseline period to after treatment
Measured: Observation periods: 1 month, 3 months, and 12 months post-treatment.
Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment
Measured: Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.
Weight: Average weight from the baseline period to post-treatment
Measured: Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.
Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%.
Measured: Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2028 (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 Mellitus (T2DM)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Zhong, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678866
- Sponsor's protocol ID
- ZLYL202601
- Status last verified
- May 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control
- ClinicalTrials.gov ID
- NCT07678866
- Acronym / sponsor ID
- ZLYL202601
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- pulsed electric field ablation system, Type 2 Diabetes Mellitus (T2DM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jul 2026 (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.
experiment design: Single-center, single-arm, open-label trial
Inclusion Criteria:
- Ages 18-70.
- At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
- The glycated hemoglobin level is 7.5%-10.5%.
- BMI 2 7-40 kg/m2.
- Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
- Stable body weight (defined as a weight change of <5% within 5 weeks prior to screening)
- Donation of blood is prohibited during the trial participation period.
- The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
- Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
- Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.
Primary efficacy endpoint :HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment Observation period: 6 months postoperatively. Secondary efficacy endpoint HbA1c: The difference in HbA1c levels from the baseline period to after treatment Observation periods: 1 month, 3 months, and 12 months post-treatment. Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Weight: Average weight from the baseline period to post-treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%.
Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Safety Indicator 1. Adverse Events and Serious Adverse Events 2. Device defect 3. Intraoperative Instrument Performance Evaluation
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The pulsed electric field ablation system in treating adult type 2 diabetes mellitus | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Ages 18-70. 2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus. 3. The glycated hemoglobin level is 7.5%-10.5%. 4. BMI 2 7-40 kg/m2. 5. Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
Key inclusion criteria (10 listed)
- Ages 18-70.
- At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
- The glycated hemoglobin level is 7.5%-10.5%.
- BMI 2 7-40 kg/m2.
- Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
Key exclusion criteria (37 listed)
- Diagnosed with type 1 diabetes mellitus.
- Severe diabetes-related complications such as diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- Fasting serum C-peptide <1 ng/mL (333 pmol/L).
- Over the past two years, insulin of any type has been used for more than 1 month (excluding treatment for gestational diabetes mellitus).
- History of ≥1 severe hypoglycemic episode within the past 6 months (defined as requiring assistance from a third party).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment
Time frame: Observation period: 6 months postoperatively.
4 secondary outcomes
HbA1c: The difference in HbA1c levels from the baseline period to after treatment
Time frame: Observation periods: 1 month, 3 months, and 12 months post-treatment.
Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment
Time frame: Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.
Weight: Average weight from the baseline period to post-treatment
Time frame: Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.
Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%.
Time frame: Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM), run by Shanghai East 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 10 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Zhong (86-131620099450, lanzhong@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment (time frame: Observation period: 6 months postoperatively.). 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 1 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.