Clinical trial NCT06452303: The Patient Cohort for Bariatric Surgery
Official title: The Patient Cohort for Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Height, Weight, Waist Circumference, Hip Circumference
Preoperative Laboratory Examination Status
Preoperative Routine Examination Results
Laboratory and Examination Results During Follow-up
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals planning to undergo bariatric surgery in China-Japan Friendship Hospital

Brief 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 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.

Primary outcomes:
measure: weight
timeFrame: Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: