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NCT Number: NCT07336862

Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

China-Japan Friendship Hospital

Beijing, China

Location status: Recruiting

Location contact

Yishan Huang, Ph.D

CONTACT

[email protected]

18810621201

About this study

"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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BS-GLP group

Combination Product
  • 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).
  • 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.

BS group

Procedure
  • 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).
  • Observation Group: Received only basic nutritional recommendation interventions after surgery.

Primary outcomes

  1. the Percentage of weight loss

    Time frame: 1 year

    Through study completion, an average of 1 year, the investigators will observe the Percentage of weight loss.

Secondary outcomes

  1. Gender

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  2. Ethnicity

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  3. Height in meters

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  4. Weight in kilograms

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  5. Waist circumference in centimeters

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  6. Hip circumference in centimeters

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  7. Blood pressure

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  8. Serum creatinine

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  9. Glomerular filtration rate

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  10. Fasting blood glucose

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  11. Average blood glucose from continuous glucose monitoring

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  12. Postprandial 2-hour blood glucose

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  13. HbA1c

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  14. Urinary microalbumin and other Urinalysis indexes

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  15. Total cholesterol

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  16. Low-Density Lipoprotein(LDL)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  17. High-Density Lipoprotein(HDL)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  18. Triglycerides

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  19. Alanine Aminotransferase(ALT)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  20. Aspartate Aminotransferase(AST)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  21. urine microalbumin-to-creatinine ratio (ACR)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  22. uric acid(UA)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Other outcomes

  1. body fat percentage(BFP)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  2. Visceral fat area

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  3. Muscle mass in kilograms

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  4. Body fat percentage

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  5. lean body mass (LBM)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

  6. lean body mass percentage (LBMP)

    Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Study contacts

Contact information is provided by the study sponsor or research team.

Yishan Huang, Ph.D

CONTACT

[email protected]

18810621201

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study

Acronym: BS-GLP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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