Understanding genetic factors that affect weight loss after bariatric 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

This observational study aims to identify genetic markers that predict weight loss outcomes in patients undergoing bariatric surgery, specifically sleeve gastrectomy or gastric bypass. By analyzing a large cohort of nearly 7,000 individuals with severe obesity, the study will utilize a multi-omics approach to discover and validate these markers. The goal is to better understand why some patients respond well to surgery while others do not, which could lead to more personalized treatment strategies for obesity. The study will also include an external validation set to enhance the reliability of the findings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men and women between the ages of 18 and 65 at the time of surgery
* SG or RYBP as bariatric procedure.
* With a BMI≥35.0 kg/m2 with one or more comorbidities or a BMI\>40.0 kg/m2 at the time of surgery.
* Provision of an informed consent form signed and personally dated by the patient.
* With available baseline data (anthropometric, analytical, surgical procedure, pharmacological therapies, and obesity-related comorbidities).

Exclusion Criteria:

* Any previous gastrointestinal surgery
* Treatment with any approved antiobesity drug in Spain (orlistat, liraglutide 3.0 mg and/or naltrexone/bupropion extended release) or systemic glucocorticoids for more than 4 consecutive weeks during the 3 years following BS
* End stage kidney disease (eGFR \<15 ml/min/1.73m2) or liver cirrhosis at baseline
* Patients who developed any major medical conditions that limits the practice of a healthy life within normal limits (advanced cardiovascular disease or heart failure, stroke with neurological sequelae, chronic pulmonary obstructive disease with dyspnea at minimal exertion, severe joint pathology, end stage renal failure, or active cancer)
* Known type 1 diabetes or LADA diabetes
* Women who become pregnant during the follow-up period
* Current drug or alcohol abuse
* Uncontrolled psychiatric illness or eating disorders developed during the follow-up period.

Where it's running

• IRBLleida
  Lleida, Leida, Spain Recruiting

Study contacts

• Principal investigator: Miguel Angel Rubio, PhD — Instituto de Investigación Sanitaria Hospital Clínico San Carlos
• Study coordinator: Albert Lecube Torelló, PhD
• Email: alecube@gmail.com
• Phone: 0034973705183

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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.