Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery (GENBASU)

March 5, 2024 updated by: Albert Lecube Torello, Institut de Recerca Biomèdica de Lleida

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

6966

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Albert Lecube Torelló, PhD
  • Phone Number: 0034973705183
  • Email: alecube@gmail.com

Study Contact Backup

Study Locations

  • Spain
    • Leida
      • Lleida, Leida, Spain, 25198
        • Recruiting
        • IRBLleida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Lleida
Saliva sample collection and questionnaire
Barcelona
Saliva sample collection and questionnaire
Madrid
Saliva sample collection and questionnaire
Málaga
Saliva sample collection and questionnaire
Santiago de Compostela
Saliva sample collection and questionnaire
Pamplona
Saliva sample collection and questionnaire
León
Saliva sample collection and questionnaire
A Coruña
Saliva sample collection and questionnaire
Mallorca
Saliva sample collection and questionnaire
Tenerife
Saliva sample collection and questionnaire
Las Palmas
Saliva sample collection and questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic markers that can predict the weight change response to bariatric surgery
Time Frame: 3 years
Percentage of initial weight change
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic markers that can predict comorbidities response to bariatric surgery
Time Frame: 3 years
Type 2 diabetes mellitus, sleep apnea, fatty liver
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recerca Biomèdica de Lleida

Collaborators

ISCIII

Investigators

  • Study Chair: Albert Lecube Torelló, PhD, Institut de recerca Biomèdica de Lleida
  • Study Director: Rafael Simo, PhD, Vall d'Hebron Research Institute
  • Principal Investigator: Miguel Angel Rubio, PhD, Instituto de Investigación Sanitaria Hospital Clínico San Carlos
  • Principal Investigator: Francisco Tinahones, PhD, Instituto de Investigación Biomédica de Málaga
  • Principal Investigator: Javier Escalada, PhD, Clínica Universidad de Navarra Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

November 29, 2028

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBLleida

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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