Bariatric Surgery Combined With GLP-1 Receptor Agonists Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BS-GLP group, BS group.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study
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.
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.
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."
Interventions
- Combination product BS-GLP 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 s - Procedure BS 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.
Primary outcome measures
- the Percentage of weight loss [Time frame: 1 year]
Secondary outcome measures (12)
- Gender [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Ethnicity [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Height in meters [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Weight in kilograms [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Waist circumference in centimeters [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Hip circumference in centimeters [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Blood pressure [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Serum creatinine [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Glomerular filtration rate [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Fasting blood glucose [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Average blood glucose from continuous glucose monitoring [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
- Postprandial 2-hour blood glucose [Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.]
Eligibility criteria
Inclusion criteria
- Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG)
- obesity:BMI ≥35 kg/m²
- Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria
- Age range: 18-60 years (inclusive)
- Informed consent: Willing participation with documented consent
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:
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT07336862 · 2023-KY-339