Last updated: June 10, 2024
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT06452303
PCBS
Ages 16-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 1、For those with simple obesity, BMI ≥ 32.5, or 27.5 ≤ BMI < 32.5, who havedifficulty controlling their condition with lifestyle modifications and medicaltreatment, and who meet at least two criteria for metabolic syndrome components, orhave comorbidities.
2、For those with simple obesity, 27.5 ≤ BMI < 32.5, and with male waistcircumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studiessuggesting central obesity.
3、For those with type 2 diabetes, BMI ≥ 27.5, who still have some residual insulinsecretion capacity.
Exclusion
Exclusion Criteria:
- 1、Non-obese type 1 diabetes; 2、Those for whom the purpose of treatment is T2DM, butwhose pancreatic beta-cell function is largely lost, with a BMI < 25.0; 3、Age < 16years or age > 65 years; 4、Pregnant women with diabetes and patients with certainspecial types of diabetes; 5、Those with a cognitive disorder or immatureintelligence, and who cannot control their behavior; 6、Those whose expectations forthe surgery are not realistic; 7、Those unwilling to assume the risks of potentialsurgical complications; 8、Those unable to comply with postoperative dietary andlifestyle changes, showing poor compliance; 9、Those in poor general health, who areunable to tolerate general anesthesia or surgery.
Study Design
Total Participants: 3000
Study Start date:
February 01, 2024
Estimated Completion Date:
September 01, 2025
Connect with a study center
China-Japan Friendship Hospital
Beijing, Beijing
ChinaActive - Recruiting

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