Weight-loss surgery plus GLP-1 medication for severe obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional trial compares laparoscopic sleeve gastrectomy alone to sleeve gastrectomy plus adjuvant GLP‑1 receptor agonist therapy in adults with severe obesity and metabolic comorbidities. Eligible participants are primary LSG candidates aged 18–60 with BMI ≥35 kg/m² and metabolic syndrome or type 2 diabetes, and they are assigned to either the BS‑GLP group or the BS group. Investigators will follow weight, glycemic and lipid markers, and safety outcomes over time to measure durability of weight loss and metabolic improvement. Key exclusions include prior bariatric surgery, recent GLP‑1RA use, advanced organ dysfunction, active malignancy, and autoimmune disease requiring immunosuppression to protect safety and reduce confounding.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG)
2. obesity:BMI ≥35 kg/m²
3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria
4. Age range: 18-60 years (inclusive)
5. Informed consent: Willing participation with documented consent

Exclusion Criteria:

1. Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively
2. Prior bariatric surgery: History of any metabolic/bariatric surgical procedure
3. Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak)
4. Non-indicated candidates: Patients not meeting standard bariatric surgery indications
5. Significant comorbidities:

   * Advanced hepatic/renal dysfunction (Child-Pugh C or eGFR \<30 mL/min/1.73m²)
   * Active malignancy (except non-melanoma skin cancers)
   * Autoimmune disorders requiring immunosuppression
   * Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression)

Where it's running

• China-Japan Friendship Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Hua Meng, Ph.D — China-Japan Friendship Hospital
• Study coordinator: Yishan Huang, Ph.D
• Email: bucmyishan@163.com
• Phone: 18810621201

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.