The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibility Study

Launched by CHINA-JAPAN FRIENDSHIP HOSPITAL · Jan 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option called gastric bypass stents for patients who have gained weight after a type of weight loss surgery known as laparoscopic sleeve gastrectomy. The goal is to see if these stents can help people manage their weight better and improve their overall health, especially those with obesity-related conditions. The study involves a team of experts from various fields, including surgery, nutrition, and traditional medicine, and aims to help reduce the healthcare burden related to obesity.

To participate in this trial, individuals must be between the ages of 18 and 65 and have a body mass index (BMI) of 27.5 or higher, which indicates overweight or obesity. Those with certain health conditions, like type 2 diabetes, may also qualify if they have some insulin production left. However, individuals who are very young, over 65, pregnant, or have specific health issues may not be eligible. Participants will have the opportunity to receive the gastric bypass stent treatment and will be monitored closely throughout the study to evaluate its effectiveness and safety. This trial is currently recruiting participants, and it's a chance for those struggling with weight regain to explore a potential new solution.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1、For those with simple obesity, BMI ≥ 32.5, or 27.5 ≤ BMI \< 32.5, who have difficulty controlling their condition with lifestyle modifications and medical treatment, and who meet at least two criteria for metabolic syndrome components, or have comorbidities.
• • 2、For those with simple obesity, 27.5 ≤ BMI \< 32.5, and with male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studies suggesting central obesity.
• • 3、For those with type 2 diabetes, BMI ≥ 27.5, who still have some residual insulin secretion capacity.
• Exclusion Criteria:
• • 1、Non-obese type 1 diabetes; 2、Those for whom the purpose of treatment is T2DM, but whose pancreatic beta-cell function is largely lost, with a BMI \< 25.0; 3、Age \< 16 years or age \> 65 years; 4、Pregnant women with diabetes and patients with certain special types of diabetes; 5、Those with a cognitive disorder or immature intelligence, and who cannot control their behavior; 6、Those whose expectations for the surgery are not realistic; 7、Those unwilling to assume the risks of potential surgical complications; 8、Those unable to comply with postoperative dietary and lifestyle changes, showing poor compliance; 9、Those in poor general health, who are unable to tolerate general anesthesia or surgery.