Obesity
Conditions
Keywords
obesity, Glucagon-Like Peptide-1 Receptor Agonist, Bariatric Surgery, multicenter
Brief summary
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. Given the lack of multi-regional validation in China's diverse population, this multicenter study aims to confirm the real-world effectiveness and generalizability of bariatric surgery plus GLP-1RA across distinct regional cohorts.
Detailed 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. Previous single-center studies have confirmed the efficacy of this combination therapy. However, given China's vast geographic and ethnic diversity, it remains unclear whether these findings are generalizable to broader populations. This multicenter study is therefore designed to assess the real-world effectiveness and generalizability of bariatric surgery plus GLP-1RA across distinct regional cohorts in China.
Interventions
COMBINATION_PRODUCTBS-GLP1RA group
1.Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2.In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the intervention group received subcutaneous semaglutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, semaglutide treatment was initiated at 1 month after LSG. The starting dose was 0.25 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 2.4 mg per week. The treatment continued until the completion of the 6-month postoperative period.
PROCEDUREBS group
1.Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2.Observation Group: Received only basic nutritional recommendation interventions after surgery.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Non-randomized assignment: A total of 400 eligible patients enrolled from participating centers were assigned to either the experimental or control group. 1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. Exposure Factor: GLP-1RA was initiated at 1 month or 3 months after surgery. 3. Grouping 3.1Observation Group: Received only basic nutritional recommendation interventions after surgery. 3.2Treatment Group: Initiated GLP-1RA at 1 month or 3 months after surgery. Based on the actual timing of use, patients were further categorized into high-, medium-, and low-exposure subgroups.
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG). 2. obesity:BMI ≥27.5 kg/m². 3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria. 4. Age range: 16-70 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the Percentage of weight loss | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Weight in kilograms | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Waist circumference in centimeters | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Serum creatinine | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Glomerular filtration rate | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Fasting blood glucose | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Postprandial 2-hour blood glucose | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| HbA1c | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Total cholesterol | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Low-Density Lipoprotein(LDL) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| High-Density Lipoprotein(HDL) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Triglycerides | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Alanine Aminotransferase(ALT) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Aspartate Aminotransferase(AST) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| uric acid(UA) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Blood pressure | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
Countries
China
Contacts
CONTACTYishan Huang
Outcome results
None listed