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NCT Number: NCT06226194

Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Genomic markers that can predict the weight change response to bariatric surgery

    Time frame: 3 years

    Percentage of initial weight change

Secondary outcomes

  1. Genomic markers that can predict comorbidities response to bariatric surgery

    Time frame: 3 years

    Type 2 diabetes mellitus, sleep apnea, fatty liver

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Lecube Torelló, PhD

CONTACT

[email protected]

0034973705183

Eva López

CONTACT

[email protected]

0034973706636

Sponsors and collaborators

Lead sponsor

Institut de Recerca Biomèdica de Lleida

Other

Collaborators

  • ISCIII

Registry information

Acronym: GENBASU

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 26, 2024
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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