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GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity

4 juni 2026 bijgewerkt door: Hua Meng, China-Japan Friendship Hospital

The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
      • Beijing, China
        • Werving
        • China-Japan Friendship Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Patients undergoing initial laparoscopic sleeve gastrectomy (LSG).
  2. obesity:BMI ≥30 kg/m².
  3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria.
  4. Age range: 18-60 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:

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: LSG-Semaglutide group

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.
Combinatie product: LSG-Semaglutide 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 LSG-Semaglutide 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.
Experimenteel: LSG-Mazdutide group

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.
Combinatie product: LSG-Mazdutide 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 LSG-Mazdutide group received subcutaneous Mazdutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, Mazdutide treatment was initiated at 1 month after LSG. 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. The treatment continued until the completion of the 6-month postoperative period.
Experimenteel: LSG-Tirzepatide group

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.
Combinatie product: LSG-Tirzepatide 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 LSG-Tirzepatide group received subcutaneous Tirzepatide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, Tirzepatide treatment was initiated at 1 month after LSG. 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. The treatment continued until the completion of the 6-month postoperative period.
Ander: LSG group
Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: N/A. Observation Group: Received only basic nutritional recommendation interventions after surgery.
Procedure: LSG 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Percentage of weight loss.
Tijdsspanne: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Gewicht in kilogram
Tijdsspanne: Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Middelomtrek in centimeters
Tijdsspanne: Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Heupomtrek in centimeters
Tijdsspanne: Onmiddellijk postoperatief (Dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
Onmiddellijk postoperatief (Dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
Bloeddruk
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Spier massa in kilogram
Tijdsspanne: Onmiddellijk postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Onmiddellijk postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Visceraal vetgebied
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Lichaamsvetpercentage
Tijdsspanne: Direct na de operatie (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct na de operatie (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Serumcreatinine
Tijdsspanne: Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Glomerulaire filtratiesnelheid
Tijdsspanne: Direct na de operatie (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct na de operatie (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Nuchtere bloedsuikerspiegel
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Gemiddelde bloedglucose uit continue glucosemonitoring
Tijdsspanne: Direct na de operatie (dag 0) en na 1, 3, 6 en 12 maanden na de operatie.
Direct na de operatie (dag 0) en na 1, 3, 6 en 12 maanden na de operatie.
Postprandiale 2-uurs bloedglucose
Tijdsspanne: Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
HbA1c
Tijdsspanne: Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Totaal cholesterol
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Low-Density Lipoproteïne (LDL)
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Triglyceriden
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Alanine Aminotransferase(ALT)
Tijdsspanne: Onmiddellijk postoperatief (Dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
Onmiddellijk postoperatief (Dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
Aspartaataminotransferase(AST)
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
lichaamsvetpercentage (BFP)
Tijdsspanne: Direct postoperatief (dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
vetvrije massa (LBM)
Tijdsspanne: Onmiddellijk postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Onmiddellijk postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
percentage vetvrije massa (LBMP)
Tijdsspanne: Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (Dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
urine microalbumine-creatinine ratio (ACR)
Tijdsspanne: Direct postoperatief (dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en op 1, 3, 6 en 12 maanden postoperatief.
urinezuur(UA)
Tijdsspanne: Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Direct postoperatief (dag 0), en na 1, 3, 6 en 12 maanden postoperatief.
Urinary microalbumin
Tijdsspanne: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Liver Stiffness Measurement(LSM)
Tijdsspanne: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Controlled Attenuation Parameter(CAP)
Tijdsspanne: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

China-Japan Friendship Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

18 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

4 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-CJH-OBE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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