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Electric pulses aim to tame type 2 diabetes

NCT ID NCT07678866

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests whether a pulse electric field ablation system can help adults with type 2 diabetes whose blood sugar is not well controlled by oral medications. The study enrolls 20 people aged 18 to 70 with a specific range of blood sugar levels. Researchers will measure changes in blood sugar control over 6 months after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulse electric field ablation system
What this could lead to
If successful, this could offer a new, non-drug option to help control blood sugar in people with type 2 diabetes.
What could go wrong
This is a very early, small study with only 20 people. The procedure may not work as hoped, and there could be unknown side effects or risks from the ablation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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. 6. Stable body weight (defined as a weight change of \<5% within 5 weeks prior to screening) 7. Donation of blood is prohibited during the trial participation period. 8. 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. 9. 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. 10. Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period. Exclusion Criteria: 1. Diagnosed with type 1 diabetes mellitus. 2. Severe diabetes-related complications such as diabetic ketoacidosis or hyperosmolar non-ketotic coma. 3. Fasting serum C-peptide \<1 ng/mL (333 pmol/L). 4. Over the past two years, insulin of any type has been used for more than 1 month (excluding treatment for gestational diabetes mellitus). 5. History of ≥1 severe hypoglycemic episode within the past 6 months (defined as requiring assistance from a third party). 6. Currently using a GLP-1RA or a dual GLP-6/GIP agonist. 7. Known autoimmune diseases. 8. 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. 9. 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. 10. History of gastroparesis. 11. Acute gastrointestinal disease has occurred within the past 7 days. 12. A history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel diseases such as Crohns disease and celiac disease is known. 13. Previous history of chronic or acute pancreatitis. 14. 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. 15. Currently, vitamin K antagonists such as warfarin are being used, or oral anticoagulants (DOCA) that cannot be safely discontinued are being administered. 16. Patients currently using P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued within 7 days prior to surgery. 17. Nonsteroidal anti-inflammatory drugs (NSAIDs) must not be discontinued within 4 weeks after treatment. Alternative use of acetaminophen and low-dose aspirin is permitted. 18. Systemic glucocorticoids (excluding topical, ocular, or inhaled formulations) were administered continuously for more than 12 days within 10 weeks prior to screening. 19. Use medications known to affect gastrointestinal motility 20. Individuals currently using weight-loss medications or over-the-counter weight-loss drugs. 21. Participate in any structured weight loss program or endoscopic weight loss intervention within 6 months after screening. 22. Persistent anemia, defined as hemoglobin \<10 g/dL. 23. Known hemoglobinopathies, hemolytic anemia or sickle cell anemia, or other known hemoglobin abnormalities that may interfere with HbA1c measurement. 24. A history of blood donation or transfusion within 3 months prior to screening. 25. Unstable or paroxysmal arrhythmia. 26. 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. 27. History of valvular heart disease or chronic heart failure (NYHA class III or IV). 28. 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. 29. There is secondary hypothyroidism or poorly controlled primary hypothyroidism (TSH levels exceed the normal range during screening). 30. During the examination, do not implant any electronic devices that cannot be turned off (such as implantable cardiac pacemakers). 31. A duodenal or biliary stent is in place. 32. Patients with contraindications to upper gastrointestinal endoscopy or intravenous anesthesia. 33. 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). 34. Breastfeeding women. 35. The participant is currently enrolled in another ongoing clinical trial. 36. 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. 37. The patient is in critical condition or has an expected lifespan of less than 5 years.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai East hospital

    RECRUITING

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.