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Recruiting Phase 1/2 NCT07336862

Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

Phase 1/2 – combined early trial
Conditions: Obesity

Sponsor: China-Japan Friendship Hospital

trial.available_in: БГ
Overview
Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with single therapies. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration require attention. GLP-1 RAs offer distinct advantages for weight and metabolic improvement, and their combined application with surgery may yield synergistic benefits. This study investigates the efficacy and safety of bariatric surgery combined with GLP-1 receptor agonist adjuvant therapy for severe obesity.
Description
"bariatric surgery is guideline-recommended as an effective obesity treatment. Substantial evidence demonstrates its ability to significantly reduce weight, improve comorbidities like type 2 diabetes (T2DM) and dyslipidemia, and lower cardiovascular risk. However, the significant heterogeneity and complex comorbidity profiles among obese patients challenge long-term effective management with single therapeutic approaches. While currently the most effective weight-loss intervention, bariatric surgery requires attention to issues such as postoperative weight regain and metabolic deterioration. In parallel, Glucagon-like peptide-1 receptor agonists (GLP-1RA) have demonstrated significant efficacy in obesity management. Agents like semaglutide promote weight loss and metabolic improvement through mechanisms including insulin secretion promotion, appetite suppression, delayed gastric emptying, and enhanced satiety. Given the distinct advantages of both bariatric surgery and GLP-1RA therapy in weight and metabolic control, this study will combine these modalities into a comprehensive treatment strategy. The investigators will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in patients with severe obesity."
Who can participate
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)
Interventions
BS-GLP group
COMBINATION_PRODUCT
BS group
PROCEDURE
Locations 1
China (1)
China-Japan Friendship Hospital
Beijing
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
01.01.2024
Completion date
01.12.2027
Registry ID
NCT07336862
Source
clinicaltrials.gov
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