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Набира участници Фаза 1/2 NCT07336862

Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Obesity

Спонсор: China-Japan Friendship Hospital

Налично на: БГ
Обобщение
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.
Описание
"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."
Кой може да участва
Inclusion Criteria: 1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG) 2. obesity:BMI ≥35 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: * 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)
Интервенции
BS-GLP group
COMBINATION_PRODUCT
BS group
PROCEDURE
Места на провеждане 1
Китай (1)
China-Japan Friendship Hospital
Beijing
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
60 Years
Здрави доброволци
Не
Начална дата
01.01.2024
Крайна дата
01.12.2027
Регистрационен номер
NCT07336862
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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