type 2 diabetes mellitus complicated with obesity
Conditions
Interventions
Treatment group :Patients with type 2 diabetes mellitus complicated with obesity receiving gastric bypass stent system implantation
Sponsors
Ningbo First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 60 years, regardless of gender. 2. Confirmed diagnosis of type 2 diabetes mellitus (T2DM). 3. Adult patients who, on the basis of diet control and exercise, have received stable doses of dual or triple combination diabetes medication for at least 3 months, yet still have poor glycemic control with 7.5% = HbA1c = 10%, and who meet one of the following criteria: (1) BMI >= 32.5 kg/m², with or without comorbidities; (2) 27.5 kg/m² <= BMI < 32.5 kg/m² with T2DM, especially those with other cardiovascular risk factors. 4. Willing to participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Weight loss >5% in 3 months pre-screening. 2. Use of NSAIDs, corticosteroids, PPIs, systemic corticosteroids, or prokinetics (e.g., metoclopramide) within 30 days pre-screening. 3. Type 1 diabetes. 4. Antibiotic use. 5. Fasting C-peptide 70 units/day. 8. Iron deficiency or IDA. 9. Coagulopathy, platelet dysfunction, or PLT = III. 12. CAD, angina, NYHA = III, or pulmonary dysfunction. 13. History of ERCP, cholecystitis, or liver abscess. 14. Duodenal/gastric ulcer or history of pancreatitis. 15. Symptomatic gallstones or stone diameter >20 mm. 16. Potential GI bleeding or telangiectasia. 17. Crohn's disease, GI malformations, or conditions precluding device placement. 18. History of intestinal obstruction within 1 year pre-screening. 19. History/family history of SLE, scleroderma, or other autoimmune CTD. 20. Uncontrolled severe infection. 21. Poor general condition with endoscopy contraindication (investigator judgment). 22. Pregnancy, lactation, or planned pregnancy. 23. Proliferative retinopathy or maculopathy needing acute treatment. 24. Drug/alcohol abuse or uncontrolled mental illness. 25. Known liver disease (viral, autoimmune, cirrhosis, cancer), excluding incidental fatty liver. 26. Severe liver dysfunction (ALT/AST >2.5×ULN, TBil >35 µmol/L) or renal dysfunction (eGFR <45 mL/min/1.73m²). 27. Thyroid dysfunction (TSH outside 0.4-4), thyroid cancer history, hyperthyroidism, or non-primary hypothyroidism on thyroid hormone. 28. Participation in another clinical trial within 3 months pre-screening. 29. Allergy to nickel-titanium. 30. Osteoporosis/osteopenia or bone-active drugs (bisphosphonates, teriparatide). 31. Blood donation/transfusion within 90 days pre-screening or planned during study. 32. Prior gastric bypass stent implantation. 33. Other conditions unsuitable per investigator judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 9 months post-stent implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HbAlc at baseline;The proportion of patients with HbA1c<7%; | — |
Countries
China
Contacts
Public ContactGuoliang Ye
Ningbo First Hospital
Outcome results
None listed