跳至主要内容
临床试验/NCT06226194
NCT06226194招募中不适用

Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery

Institut de Recerca Biomèdica de Lleida1 个研究点 分布在 1 个国家目标入组 6,966 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
6,966
试验地点
1
主要终点
Genomic markers that can predict the weight change response to bariatric surgery

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Genomic markers that can predict the weight change response to bariatric surgery

时间窗: 3 years

Percentage of initial weight change

次要结局

  • Genomic markers that can predict comorbidities response to bariatric surgery(3 years)

研究者

发起方
Institut de Recerca Biomèdica de Lleida
申办方类型
Other
责任方
Principal Investigator
主要研究者

Albert Lecube Torello

Head of Endocrinology Department Arnau de Vilanova University Hospital

Institut de Recerca Biomèdica de Lleida

研究点 (1)

Loading locations...

相似试验