NCT06226194Recruiting
Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery
Source: ClinicalTrials.gov · Last updated 6 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6966 (estimated)
- First submitted
- 17 Jan 2024
- Start date
- 15 Mar 2024
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida
- Diseases
- Obesity
- NCT number
- NCT06226194
What you commit to
- Study type: Observational
- Planned participants: 6966
- From 15 Mar 2024 to the primary completion date, 15 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Current drug or alcohol abuse
Other illness
- 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
- Uncontrolled psychiatric illness or eating disorders developed during the follow-up period.
Lab values
- End stage kidney disease (eGFR \<15 ml/min/1.73m2) or liver cirrhosis at baseline
Other
- Women who become pregnant during the follow-up period
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRBLleida Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.