Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with monotherapy. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration remain significant concerns. glucagon-like peptide-1 receptor agonists (GLP-1RA) offer distinct advantages for weight loss and metabolic control, and their combination with surgery may produce synergistic effects. This study investigates the efficacy and safety of bariatric surgery combined with adjuvant GLP-1 receptor agonist therapy for Chinese patients with 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. Tirzepatide, as the first approved GLP-1/GIP dual-target agonist, demonstrates superior hypoglycemic and weight loss effects compared to Semaglutide through its synergistic interaction with GLP-1. Mazdutide, the first GLP-1/GCG dual-target agonist to enter phase III clinical trials in China, promotes fatty acid oxidation and energy consumption while acting synergistically with GLP-1's appetite-suppressing effect. It can effectively reduce liver fat content while achieving weight loss.
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. We will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in Chinese patients with obesity.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSG-Semaglutide 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. |
|
| LSG-Mazdutide group | Experimental | Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs:Mazdutide. Dosage:The starting dose was 2 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 6 mg per week. Frequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period. |
|
| LSG-Tirzepatide group | Experimental | Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs:Tirzepatide. Dosage:The starting dose was 2.5 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 10 mg per week. Frequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period. |
|
| LSG 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 |
|---|---|---|---|---|
| LSG-Semaglutide group | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of weight loss. | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Measure | Description | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
5.1Advanced hepatic/renal dysfunction (Child-Pugh C or eGFR <30 mL/min/1.73m²). 5.2Active malignancy (except non-melanoma skin cancers). 5.3Autoimmune disorders requiring immunosuppression. 5.4Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression).
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yishan Huang, Ph.D | Contact | +8618612256920 | yuanwen0920@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Non-randomized assignment: A total of 200 eligible patients were assigned to either the Semaglutide(n=50) 、Mazdutide (n=50)、Tirzepatide(n=50)、control(n=50) group.
3.2Treatment Group: Initiated Semaglutide,Mazdutide,Tirzepatide at 1 month after surgery.
Not provided
Not provided
The decision to add GLP-1RAs as adjuvant therapy after sleeve gastrectomy, including which specific drug to use, is made by the attending physicians based on each patient's clinical condition. The researchers do not intervene in the treatment assignment for any patient.
Not provided
|
|
| LSG-Mazdutide group | Combination Product |
|
|
| LSG-Tirzepatide group | Combination Product |
|
|
| LSG group | Procedure |
|
|
| 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 | 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. |
| 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. |
| 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. |
| 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. |
| Liver Stiffness Measurement(LSM) | Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively. |
| Controlled Attenuation Parameter(CAP) | 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 |