Search / Trial NCT06226194

Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery

Launched by INSTITUT DE RECERCA BIOMÈDICA DE LLEIDA · Jan 17, 2024

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Trial Information

Current as of December 31, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how genetics and other factors can help predict how well people will lose weight after bariatric surgery, which is a type of surgery to help with severe obesity. The researchers want to understand why some patients lose weight successfully while others do not, as about 30% of people do not achieve satisfactory results from this surgery. They will gather information from nearly 7,000 men and women who have had either sleeve gastrectomy or gastric bypass surgery and analyze various genetic and health factors to find out what influences weight loss and maintenance over 3 years.

To participate in this trial, you must be between 18 and 65 years old and have a body mass index (BMI) of 35 or higher with related health issues, or a BMI over 40. You should not have had any previous gastrointestinal surgeries or be currently using certain weight loss medications. If you decide to join, you can expect to provide some detailed health information and undergo regular follow-ups to track your weight loss progress and any changes in your health. This trial aims to improve treatment for obesity by tailoring approaches to individual needs, which could lead to better outcomes in the future.

Gender

ALL

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.

Trial Officials

Albert Lecube Torelló, PhD

Study Chair

Institut de Recerca Biomèdica de Lleida

Rafael Simo, PhD

Study Director

Vall d'Hebron Research Institute

Miguel Angel Rubio, PhD

Principal Investigator

Instituto de Investigación Sanitaria Hospital Clínico San Carlos

Francisco Tinahones, PhD

Principal Investigator

Instituto de Investigación Biomédica de Málaga

Javier Escalada, PhD

Principal Investigator

Clínica Universidad de Navarra Institute

About Institut De Recerca Biomèdica De Lleida

The Institut de Recerca Biomèdica de Lleida (IRBLleida) is a leading biomedical research institute dedicated to advancing scientific knowledge and improving healthcare outcomes through innovative research. Located in Lleida, Spain, the institute focuses on translational medicine, bridging laboratory discoveries with clinical applications. IRBLleida fosters collaboration among researchers, healthcare professionals, and industry partners, emphasizing a multidisciplinary approach to tackle pressing health challenges. With a commitment to excellence in research and a strong emphasis on patient-centered outcomes, IRBLleida plays a pivotal role in driving advancements in biomedical science and enhancing the quality of life within the community.

Locations

Lleida, Leida, Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0