Clinical trial NCT06226194: Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery
Official title: Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Obesity, Morbid
Genetic Predisposition
Metabolic Syndrome
Weight Loss
Lead sponsor: Institut de Recerca Biomèdica de Lleida
Sponsor class: OTHER
Collaborators: name: ISCIII
First posted: 2024-01-26
Enrollment: 6966
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This multicenter retrospective study will be aimed at 6,966 obese patients undergoing BS, whose surgical technique (sleeve gastrectomy vs gastric bypass) has been performed at least 3 years before, evaluating the best combination of genetic and exposomal characteristics (clinical and analytical) that will predict which patients will be responders and non-responders in terms of weight loss.

Brief summary: Obesity is a complex chronic disease, in which both genetic and environmental factors are involved, that shows a great heterogeneity in the response to different weight loss programs. Identifying patients as responder or no responder to the different obesity treatment options is a concept of great interest, both due to the high prevalence of obesity and its high consumption of resources. More than 500,000 surgeries are performed every year around the world, of which approximately 30% will present unsatisfactory results.

The general objective is to carry out a multi-omics approach for the discovery and validation of markers of weight response to bariatric surgery (BS) in a large sample of people with severe obesity (n=6,966 men and women who underwent sleeve gastrectomy or gastric bypass, including an additional external validation set). Thus, the investigators want to know the integrated contribution of several genomic markers (Genome Wide Association study, GWAs), new clinical and analytical variables (human exposome concept) and gender perspective to the prediction of response to the intervention at 12 month and its long-term longitudinal maintenance (3 years). The investigators intend, therefore, to provide new evidence to advance towards precision medicine. The investigators will focus our attention also on identifying those patients who, after being classified at the weight loss nadir as responders experienced weight regain.


Eligibility 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.

Primary outcomes:
measure: Genomic markers that can predict the weight change response to bariatric surgery
timeFrame: 3 years
Secondary outcomes:
measure: Genomic markers that can predict comorbidities response to bariatric surgery
timeFrame: 3 years
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: IRBLleida
state: Leida
Study officials:
affiliation: Institut de Recerca Biomèdica de Lleida
name: Albert Lecube Torelló, PhD
role: STUDY_CHAIR
affiliation: Vall d'Hebron Research Institute
name: Rafael Simo, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Investigación Sanitaria Hospital Clínico San Carlos
name: Miguel Angel Rubio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Investigación Biomédica de Málaga
name: Francisco Tinahones, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universidad de Navarra Institute
name: Javier Escalada, PhD
role: PRINCIPAL_INVESTIGATOR
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