The Patient Cohort for Bariatric Surgery

Last updated: June 10, 2024
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06452303
PCBS
  • Ages 16-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1、For those with simple obesity, BMI ≥ 32.5, or 27.5 ≤ BMI < 32.5, who havedifficulty controlling their condition with lifestyle modifications and medicaltreatment, and who meet at least two criteria for metabolic syndrome components, orhave comorbidities.

2、For those with simple obesity, 27.5 ≤ BMI < 32.5, and with male waistcircumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studiessuggesting central obesity.

3、For those with type 2 diabetes, BMI ≥ 27.5, who still have some residual insulinsecretion capacity.

Exclusion

Exclusion Criteria:

  • 1、Non-obese type 1 diabetes; 2、Those for whom the purpose of treatment is T2DM, butwhose pancreatic beta-cell function is largely lost, with a BMI < 25.0; 3、Age < 16years or age > 65 years; 4、Pregnant women with diabetes and patients with certainspecial types of diabetes; 5、Those with a cognitive disorder or immatureintelligence, and who cannot control their behavior; 6、Those whose expectations forthe surgery are not realistic; 7、Those unwilling to assume the risks of potentialsurgical complications; 8、Those unable to comply with postoperative dietary andlifestyle changes, showing poor compliance; 9、Those in poor general health, who areunable to tolerate general anesthesia or surgery.

Study Design

Total Participants: 3000
Study Start date:
February 01, 2024
Estimated Completion Date:
September 01, 2025

Connect with a study center

  • China-Japan Friendship Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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