Current partner codePEPTIDESDE
NCT07732738·Not applicable·INTERVENTIONAL

Bariatric Surgery Combined With GLP-1RA: A Multicenter Study.

Status

Recruiting

Phase

Not applicable

Enrollment

400

Locations

7

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

COMBINATION_PRODUCT

BS-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.

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.

Timeline

From registration to results.

  1. First posted

    Jul 29, 2026

  2. Study start

    Jan 1, 2025

  3. Primary completion

    Dec 30, 2027

  4. Study completion

    Dec 30, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 29, 2026

Outcomes

What the study measures.

Primary outcomes

the Percentage of weight loss

Time frame · 1 year

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
16 Years
Maximum age
70 Years
Sex
ALL
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)

Study locations

7 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Xingtai Ninth Hospital

Xingtai, Hebei, China

Zhengzhou Central Hospita

Zhengzhou, Henan, China

The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China

The Second Hospital, Cheeloo College of Medicine, Shandong University

Jinan, Shandong, China

Sinopharm Tongmei General Hospital

Datong, Shanxi, China

The First People Hospital Of Yunnan Province

Kunming, Yunnan, China

China-Japan Friendship Hospital

Beijing, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.