Obesity and Obesity-related Medical ConditionsDJBL for LSGNCT06801496
The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibility Study
An observational study of Obesity and Obesity-related Medical Conditions and Weight Regain, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Weight Regain
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals planning to undergo bariatric surgery in China-Japan Friendship Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital, Beijing, Beijing
Beijing
+86-18801392133, cicamslzq@163.com
About this study
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.
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measured: Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Meng, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801496
- Sponsor's protocol ID
- 2023-KY-125
- Acronym
- DJBL for LSG
- Status last verified
- Jun 2024
- First submitted
- 25 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibility Study
- ClinicalTrials.gov ID
- NCT06801496
- Acronym / sponsor ID
- DJBL for LSG / 2023-KY-125
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals planning to undergo bariatric surgery in China-Japan Friendship Hospital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
weight
Time frame: Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity-related Medical Conditions and Weight Regain, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Meng, Doctror (18611457779, menghuade@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.