Type 2 diabetes
Conditions
Interventions
treatment group:Duodenal mucosal surface remodeling surgery
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
28 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 28-75 years (including 28 and 75 years); 2. Diagnosed with type 2 diabetes for less than 10 years; 3. Glycated hemoglobin (HbA1c) 7.5-10.0% (59-86 mmol/mol); 4. Body mass index (BMI) >=24 and <=40 kg/m^2; 5. Taking at least one oral hypoglycemic drug at a stable dose (one of which must be metformin), with no adjustment in medication regimen within 12 weeks prior to enrollment; 6. Voluntarily participates in this study and signs the informed consent form, willing to comply with research-related requirements, and willing to complete follow-up as required by the protocol.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Confirmed type 1 diabetes or history of diabetic ketoacidosis; 2. Possible insulin secretion failure, defined as fasting serum C-peptide <1 ng/mL (333 pmol/L); 3. Currently using insulin; 4. Using glucagon-like peptide-1 (GLP-1) receptor agonists; 5. Hypoglycemia unawareness or history of severe hypoglycemia (at least one severe hypoglycemic event in the past year, defined as requiring third-party assistance); 6. Known autoimmune diseases (positive anti-glutamic acid decarboxylase (GAD) antibody test), including celiac disease; or a history of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disease symptoms; 7. Previous gastrointestinal (GI) surgery that may affect duodenal treatment, such as Billroth II procedure, Roux-en-Y gastric bypass, or other similar surgeries/situations; 8. History of chronic or acute pancreatitis; 9. Known active hepatitis or active liver disease; 10. Symptomatic gallstones or kidney stones, acute cholecystitis, or history of duodenal inflammatory disease (including Crohn's disease, celiac disease); 11. History of bleeding disorders, upper gastrointestinal bleeding-related diseases (such as ulcers, gastric varices, stenosis, congenital or acquired intestinal telangiectasia); 12. Using anticoagulant therapy (e.g., warfarin) and unable to discontinue from 7 days before to 14 days after surgery; 13. Using P2Y12 receptor inhibitors (clopidogrel, prasugrel, ticagrelor) and unable to discontinue from 14 days before to 14 days after surgery (aspirin use is allowed); 14. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment up to 4 weeks post-surgery; 15. Currently taking glucocorticoids or known drugs that affect gastrointestinal motility (e.g., metoclopramide); 16. Currently taking weight loss drugs (e.g., sibutramine, orlistat) or non-prescription weight loss drugs; 17. Persistent anemia, defined as hemoglobin (Hgb) <10 mg/dL; 18. Estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease (MDRD) formula <30 mL/min/1.73 m^2; 19. Active systemic infection; 20. History of active malignancy within the past 5 years; 21. Unsuitable for surgery or general anesthesia; 22. Active illegal drug use or alcohol dependence; 23. Pregnant, breastfeeding, or planning pregnancy during the study period; 24. Currently participating in other investigational drug or device clinical trials (if the investigational product of a trial has been marketed, participation in extended follow-up of the marketed product is allowed); 25. Any other mental or physical condition that, in the investigator's judgment, makes the participant unsuitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of serious adverse events (SAEs) related to devices or procedures 4 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in patient-reported satisfaction (Diabetes Treatment Satisfaction Questionnaire, DTSQs) 4 weeks post-surgery compared with baseline;Change in body weight from baseline at 4 weeks, 6 months and 12 months post-surgery;Changes in the dosage and type of oral antidiabetic medication at 4 weeks, 6 months and 12 months post-surgery compared with baseline; | — |
Countries
China
Contacts
Public ContactHuang Kai
Renmin Hospital of Wuhan University
Outcome results
None listed