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

NCT ID: NCT06801496

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-31

Brief Summary

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This study is based on the National Center for Integrated Traditional Chinese and Western Medicine, utilizing the centralized advantages of our department and integrating multiple disciplines (general surgery, endocrinology, nutrition, sports, and traditional Chinese medicine). It focuses on the effectiveness of gastric bypass stents in treating patients with postoperative obesity after laparoscopic sleeve gastrectomy, as well as in patients with simple obesity. This will improve the prognosis of patients and reduce the medical burden.

Detailed Description

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Conditions

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Obesity and Obesity-related Medical Conditions Weight Regain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hua Meng

irector of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital, Beijing, Beijing

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Meng, Doctror

Role: CONTACT

18611457779

Facility Contacts

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Role: primary

+86-18801392133

Other Identifiers

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2023-KY-125

Identifier Type: -

Identifier Source: org_study_id

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