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.
"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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
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.
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.
Xingtai Ninth Hospital
Xingtai, Hebei, China
RECRUITINGZhengzhou Central Hospita
Zhengzhou, Henan, China
RECRUITINGThe Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, China
RECRUITINGThe Second Hospital, Cheeloo College of Medicine, Shandong University
Jinan, Shandong, China
RECRUITINGSinopharm Tongmei General Hospital
Datong, Shanxi, China
RECRUITINGThe First People Hospital Of Yunnan Province
Kunming, Yunnan, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, China
RECRUITINGthe Percentage of weight loss
Time frame: 1 year
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.
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.
Postprandial 2-hour blood glucose
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
HbA1c
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Total cholesterol
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Low-Density Lipoprotein(LDL)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
High-Density Lipoprotein(HDL)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Triglycerides
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Alanine Aminotransferase(ALT)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Aspartate Aminotransferase(AST)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
uric acid(UA)
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.
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