The Patient Cohort for Bariatric Surgery

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: Height, Weight, Waist Circumference, Hip Circumference; Preoperative Laboratory Examination Status; Preoperative Routine Examination Results; Laboratory and Examination Results During Follow-up

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Hua Meng, doctor; Phone Number: 18611457779; Email: menghuade@hotmail.com

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

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