Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT06226194

Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery

Led by Institut de Recerca Biomèdica de Lleida · Updated on 2024-03-06

6966

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

Sponsors

I

Institut de Recerca Biomèdica de Lleida

Lead Sponsor

I

ISCIII

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women between the ages of 18 and 65 at the time of surgery
  • Underwent sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYBP) as bariatric procedure
  • Body mass index (BMI) of 35.0 kg/m2 or higher with one or more related health problems, or BMI over 40.0 kg/m2 at surgery
  • Signed and personally dated informed consent form
  • Available baseline data including body measurements, lab tests, surgical details, medications, and obesity-related conditions
Not Eligible

You will not qualify if you...

  • Any previous gastrointestinal surgery
  • Treatment with approved antiobesity drugs in Spain (orlistat, liraglutide 3.0 mg, or naltrexone/bupropion extended release) or systemic glucocorticoids for more than 4 consecutive weeks during the 3 years after surgery
  • End stage kidney disease (eGFR less than 15 ml/min/1.73m2) or liver cirrhosis at baseline
  • Major medical conditions limiting normal healthy life (advanced cardiovascular disease, heart failure, stroke with neurological effects, chronic pulmonary disease with breathlessness on minimal exertion, severe joint problems, end stage kidney failure, or active cancer)
  • Known type 1 diabetes or LADA diabetes
  • Women who become pregnant during follow-up
  • Current drug or alcohol abuse
  • Uncontrolled psychiatric illness or eating disorders during follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

IRBLleida

Lleida, Leida, Spain, 25198

Actively Recruiting

Loading map...

Research Team

A

Albert Lecube Torelló, PhD

CONTACT

E

Eva López

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

11

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here