Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
IRBLleida
Lleida, Leida, Spain, 25198
Actively Recruiting
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
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