T2DM
Conditions
Interventions
Experimental group:Gastroscopy-assisted pulsed electric field duodenal mucosal surface reconstruction
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 70 years old. 2. At least diagnosed with type 2 diabetes for 6 months before enrollment. 3. Glycated hemoglobin level: 7.5% - 10.5%. 4.BMI 27-40 kg/m^2. 5. Those who have received treatment with 2-3 types of oral hypoglycemic drugs for at least 12 weeks but still have poor blood sugar control, and who can maintain the same medication regimen during the trial; or those whose blood sugar control has not reached the standard through lifestyle adjustments. 6. Stable weight (defined as a weight change of less than 5% within 5 weeks before screening) 7. Agree not to donate blood during the trial participation. 8. The subjects must sign the Informed Consent Form (ICF), indicating that they understand the purpose of this study and the required procedures, and are willing to participate in the study. 9. Willing and able to follow all requirements of the trial, including but not limited to completing the necessary assessments, following the visit plan, and adhering to lifestyle restrictions. 10. Female subjects of reproductive age must have a negative urine pregnancy test result at the screening stage, and will receive contraception throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with type 1 diabetes. 2. History of severe diabetes-related complications such as diabetic ketoacidosis or hyperosmolar non-ketotic coma. 3. Fasting serum C-peptide 1 month within the past two years (excluding gestational diabetes treatment). 5. Having experienced >=1 episode of severe hypoglycemia (defined as requiring third-party assistance) within the past 6 months. 6. Currently using GLP-1RA or GLP-6/GIP dual agonists. 7. Known autoimmune diseases. 8. Previous gastrointestinal surgery that has altered the anatomical structure of the gastrointestinal tract or may limit duodenal treatment, such as Billroth 2, Roux-en-Y gastric bypass surgery, gastric banding, or other similar surgeries or diseases. 9. Known structural or functional abnormalities of the upper gastrointestinal tract may hinder the passage of devices through it or increase the risk of tissue damage during endoscopic surgery, including upper gastrointestinal stenosis, esophageal-gastric varices, giant diverticula, or other severe diseases of the esophagus, stomach, and duodenum. 10. History of gastroparesis. 11. Acute gastrointestinal illness occurred within the past 7 days. 12. Known history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel diseases such as Crohn's disease and celiac disease. 13. Previous history of chronic or acute pancreatitis. 14. Active hepatitis or active liver disease, or an alanine aminotransferase (ALT) level determined by the central laboratory at the time of screening visit that is greater than 3.0 times the upper limit of normal (ULN). 15. Currently taking vitamin K antagonists such as warfarin, or currently taking oral anticoagulants (DOCA) that cannot be safely discontinued. 16. Patients currently using P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) and unable to discontinue them within 7 days before surgery. 17. Non-steroidal anti-inflammatory drugs (NSAIDs) cannot be discontinued within 4 weeks after treatment. Alternative use of acetaminophen and low-dose aspirin is permitted. 18. Continuous use of systemic glucocorticoids (excluding topical, ophthalmic, or inhaled medications) for more than 12 days within the 10 weeks prior to screening. 19. Using drugs known to affect gastrointestinal motility 20. Currently using weight loss drugs or non-prescription weight loss medications. 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 hemoglobinopathy, hemolytic anemia, sickle cell anemia, or other known hemoglobin abnormalities that interfere with HbA1c measurement. 24. History of blood donation or blood transfusion within 3 months prior to screening. 25. Unstable or paroxysmal arrhythmia. 26. Any of the following cardiovascular diseases occurring within 6 months before screening: acute myocardial infarction, cerebrovascular accident (stroke), hospitalization due to congestive heart failure. 27. History of valvular heart disease or chronic heart failure (NYHA ? or ?). 28. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, have clinically significant leukopenia, are HIV-positive, or whose immune status makes them, in the opinion of the investigator, unsuitable for participation in cl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin;Mean fasting blood glucose;Weight;Use of hypoglycemic drugs; | — |
Countries
Chian
Contacts
Public ContactLan Zhong
Shanghai East Hospital
Outcome results
None listed