Understanding genetic factors that affect weight loss after bariatric surgery
Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery
This study is trying to find out if certain genes can help predict how well people with severe obesity will lose weight after having bariatric surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6966 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institut de Recerca Biomèdica de Lleida Academic / other |
| Locations | 1 site (Lleida, Leida) |
| Trial ID | NCT06226194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 18 to 65 with a BMI of 35 or higher and related comorbidities, or a BMI over 40.
Not a fit: Patients with previous gastrointestinal surgeries or those with severe medical conditions that limit healthy living may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for bariatric surgery, enhancing weight loss outcomes and reducing healthcare costs associated with ineffective treatments.
How similar studies have performed: Other studies have explored genetic factors in obesity treatment, but this specific multi-omics approach in a large cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lleida, Leida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.