Electric pulses aim to tame type 2 diabetes
NCT ID NCT07678866
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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shanghai East hospital
RECRUITINGShanghai, China
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