The Patient Cohort for Bariatric Surgery

June 10, 2024 updated by: Hua Meng, China-Japan Friendship Hospital
This study is based at the National Integrated Traditional Chinese and Western Medicine Medical Center and leverages the centralized strengths of our department, which integrates multiple disciplines (general surgery, endocrinology, nutrition, exercise, and traditional Chinese medicine). It focuses on key scientific issues in the comprehensive management of bariatric surgery throughout the entire treatment cycle. By recording key indicators of patients before and after surgery and using methods such as machine learning to predict postoperative complications, we aim to enhance precision management. Ultimately, we will establish a refined diagnosis and treatment system for metabolic weight loss surgery, promote its application, and thereby raise the standardized management level of weight loss and metabolic disciplines in our hospital and primary care units nationwide. This will improve patient outcomes and reduce the healthcare burden.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals planning to undergo bariatric surgery in China-Japan Friendship Hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight
Time Frame: Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PCBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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