Classification and real-time risk-warning system for people having bariatric metabolic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will enroll a prospective cohort of 2,000 adults undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass and collect clinical, laboratory, and multi-omics samples before surgery and at multiple postoperative time points through 24 months. Researchers will integrate time-series biospecimens and clinical data on a multidimensional platform and use clustering and machine learning to identify features linked to postoperative adverse events. Targeted assays will seek novel biomarkers and a risk warning model will be developed, validated, and evaluated. The final aim is to implement an intelligent digital system that combines patient classification with real-time risk alerts to support clinicians and patients in postoperative management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who meet the clinical indications for bariatric/metabolic surgery;

  * Adults aged 18 to 50 years; ③ Stable body weight (change within ±5% over the past 3 months); ④ Undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB).

Exclusion Criteria:

* ① Patients with conditions affecting the immune or metabolic systems (e.g., endocrine disorders such as untreated hypothyroidism/hyperthyroidism, cancer);

  * Patients with renal or hepatic impairment;

    * Patients who have taken medications that may affect metabolism within the past 3 months (e.g., weight-loss drugs, asthma medications, psychiatric medications, corticosteroids);

      * Patients who have previously undergone bariatric surgery and are undergoing revisional surgery; ⑤ Patients with psychiatric disorders, especially those with comorbid behavioral or personality disorders (e.g., binge eating disorder);

        * Patients currently participating in other clinical studies that may conflict with this study or those who refuse to sign the informed consent form.

Where it's running

• Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Liyong Zhu
• Email: zly8128@csu.edu.cn
• Phone: +86 13975879453

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.