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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.
"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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BS-GLP group | Experimental | Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: Semaglutide. Dosage: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. Frequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period. |
|
| BS group | Other | Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: N/A. Observation Group: Received only basic nutritional recommendation interventions after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BS-GLP group | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Percentage of weight loss | Through study completion, an average of 1 year, the investigators will observe the Percentage of weight loss. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Gender | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. | |
| Ethnicity | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. | |
| Measure | Description | Time Frame |
|---|---|---|
| body fat percentage(BFP) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. | |
| Visceral fat area | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
Inclusion Criteria:
Exclusion Criteria:
Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively
Prior bariatric surgery: History of any metabolic/bariatric surgical procedure
Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak)
Non-indicated candidates: Patients not meeting standard bariatric surgery indications
Significant comorbidities:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yishan Huang, Ph.D | Contact | 18810621201 | bucmyishan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hua Meng, Ph.D | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| BS group | Procedure |
|
|
| Height in meters |
| Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| 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. |
| Hip circumference in centimeters | 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. |
| 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. |
| Average blood glucose from continuous glucose monitoring | 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. |
| Urinary microalbumin and other Urinalysis indexes | 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. |
| urine microalbumin-to-creatinine ratio (ACR) | 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. |
| Muscle mass in kilograms | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Body fat percentage | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| lean body mass (LBM) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| lean body mass percentage (LBMP) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |