Cohorte Obésité Bichat LOuis Mourier
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- number of biological samples collected
研究概览
简要总结
Obesity prevalence rapidly increased in the past decades in French population with multiple health consequences responsible for excess mortality. In the same period of time, the number of bariatric procedures have developed exponentially. Despite its great efficacy on weight loss but also on resolution of comorbidities, bariatric surgery is not without risks. Our hypothesis is that a better understanding of the physio-pathological consequences of obesity and bariatric surgery, notably on the gastrointestinal tract, may allow to improve the treatment of obesity and to find alternatives to bariatric surgery.
The main objective of this cohort study is to systematize the collection and the conservation of biological samples (blood, stomach, liver, intestine, adipose tissue) obtained during bariatric surgery, in obese subjects undergoing surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or revisional intervention for complication or weight regain) in the University Hospital group of Paris Nord Val de Seine (HYPNVS).
The main projects that will build on this cohort will cover the physiopathology of obesity and its consequences, notably in the field of gastrointestinal tract including: modification of gastro-intestinal plasticity in severe obesity and after bariatric surgery and alterations of absorption of nutriments (lipids, proteins, carbohydrates) induced by obesity and bariatric surgery. The inclusion in this project of obese subjects before surgery, or lean or obese subjects after surgery will allow to distinguish the impact of weight loss and surgery on gastrointestinal remodeling. This cohort will also allow to characterize stomach and intestinal proteome in severe obesity and to precise the influence of tissue inflammation on metabolic disorders associated with obesity.
详细描述
The prevalence of obesity rapidly increased in the past decades in the French population with multiple health consequences (including hypertension, diabetes, sleep apnea syndrome, cardiovascular events, cancers…) responsible for excess mortality. In the same period of time, the number of bariatric procedures has developed exponentially. Indeed, there is presently little or no therapeutic alternatives in severe obesity, the pharmacotherapy of obesity having a poor efficacy. Despite its great efficacy on weight loss and resolution of comorbidities, bariatric surgery is not without risks. Indeed, it can be accompanied by side effects, including gastrointestinal disorders (transit disturbances, gastro-esophageal reflux, or dumping syndrome), surgical complications (gastric fistulas and bowel obstruction) and multiples nutritional deficiencies deleterious for health (anemia, neurological complication, bone loss, and protein malnutrition).
The mechanisms of development of obesity are still imperfectly known and, moreover, the observations made in murine models are not always transposable to humans. This is why it is necessary to establish human cohorts to specify better the pathophysiological mechanisms underlying the development of obesity and its complications and to identify new markers of response to medical and surgical treatments of obesity, in order to propose targeted therapies. In particular, the digestive tract, at the interface between the intake of nutrients and their metabolism, has a central role both in the development of obesity and in the effects of bariatric surgery.
Since 2000, bariatric surgery has been developed in University Hospital group of Paris Nord Val de Seine (HYPNVS) with a significant activity of about 600 procedures per year (mainly gastric bypass and sleeve gastrectomy). The well-systematized multidisciplinary clinical management makes it possible to phenotype the patients precisely. The collaboration between the obesity center and the INSERM 1149 research team promotes the implementation of transversal projects ranging from clinical research to basic research to deepen the physio-pathological mechanisms of obesity. Some perioperative biological samples (blood, DNA, adipose tissue, liver, intestine) were temporally collected in the surgical cohort of HUPNVS, leading to several research projects and international publications.
The team focuses on the mechanisms of gastrointestinal changes during obesity and bariatric surgery and previously showed profound changes in intestinal architecture, permeability, transport functions, metabolism, or in neuro-hormonal activity of the digestive tract. In these studies, it has been observed a plasticity of the epithelial cells constituting the gastrointestinal tract (including endocrine cells and enterocytes) that needs to be further documented. This plasticity that affects self-renewal, endocrine and digestive system and enteric nervous system, may allow epithelia to adapt to changes in the luminal environment (nutritional changes, modification of the microbiota, etc.) induced by obesity and bariatric surgery. Similarly, the connections of gastrointestinal tract with other tissues involved in metabolism and in particular the liver and adipose tissues affected by chronic inflammation and whose functions are impaired during obesity should be explored.
Our hypothesis is that a better understanding of the physio-pathological consequences of obesity and bariatric surgery, notably on the gastrointestinal tract, may allow to improve the treatment of obesity and to find alternatives to bariatric surgery.
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
- 否
入选标准
- •severe obese subject with BMI above35 kg/m2, age above 18 ans who accept to participate
- •candidate for bariatric surgery according to HAS criteria
- •who will undergo either sleeve gastrectomy or gastric bypass
- •or who undergoesa revisional surgery for a complication of bariatric surgery
- •or who undergoes arevisional sugery fir insufficient weight loss
- •covered by an health insurance
排除标准
- •psychiatric disease or undertanding disorder
- •alchool abuse or other addiction
- •organ failure (including liver, heart or kidney)
- •chronic life-threatening illness
- •inflamatory disease or immunosuppressive treatment
结局指标
主要结局
number of biological samples collected
时间窗: during surgery
liver stomach and intestin samples will be performed during surgery for usual care. Adiposes tissues and blood samples will be performed for reseach, on the surgical site
次要结局
- tissue inflammation and fibrosis(samples collected during surgery)
- modifications of gastro-intestinal plasticity induces by obesity and bariatric surgery(samples collected during surgery)
- alterations of absroption and metabolism of nutriments induced by obesity and bariatric surgery(samples collected during surgery)
- gastric and intestinal proteome(samples collected during surgery)
