Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Analyse changes early, medium and long term changes in gut microbiota composition in a kinetic manner
研究概览
简要总结
Gut microbiota ecology is altered in obesity and could link obesity and its complications. Bariatric surgery enables a major and sustained weight loss therefore improving obesity related disease.
the investigators primary aim is to evaluate gut microbiota adaptation to weight loss and the specific role of energetic restriction. Furthermore we aim to compare gut flora of obese patients post bariatric surgery to that of lean healthy volunteers.
Thus, the investigators plan to compare gut microbiota from 140 obese individuals before and after either restrictive (gastric banding) procedures or gastric bypass procedures to that of 40 lean healthy volunteers at baseline.
详细描述
The prevalence of obesity is rising to an epidemic level. Yet medical and pharmacological treatments have proven their limits. Dietetic modifications contribute to adipose tissue alterations and cross talk dysfunction with other tissues linked to weight maintenance. In a previous study in a model of abrupt weight loss 6 months after Roux-en-Y Bypass, the investigators observed a rapid adaptation of the dominant gut microbiota. Conversely some species were directly linked to the improvement of low grade inflammation independently of calory intake.
Therefore the investigators hypothesized that gut microbiota in obese patients could link food consumption with obesity alterations such as metabolic impairments, energetic storage dysfunction and increased systemic and adipose tissue inflammation.
The investigators want to address the specific role of energetic restriction in gut microbiota modification after weight loss.
To answer that question the investigators will evaluate gut microbiota composition before and during the first year after either gastric banding or gastric bypass surgery. they also aim to evaluate whether gut flora post surgery evolves toward that of lean healthy subjects Our study has several objectives. The investigators also aim to assess whether gut microbiota modification is associated with systemic and tissue inflammation reduction and metabolic improvement during the follow up.
This project is based on a clinical protocol performed in massively obese subjects (BMI>40 kg/m²). The investigators plan to recruit 70 obese patients addressed for gastric banding and 70 candidates for gastric bypass. Clinical phenotype, biochemical analysis, body composition, systemic and adipose tissue inflammation, endotoxemia and gut microbiota will be assessed at baseline and 1, 3 and 12 months after surgery. Specific food consumption will be recorded at every time point. A group of 40 lean healthy volunteers will undergo the same phenotyping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
gastric surgery
obese patients addressed for gastric surgery
干预措施: stools sampling (Other)
gastric surgery
obese patients addressed for gastric surgery
干预措施: adipose tissue biopsy (Other)
lean healthy subjects evaluated once
lean healthy subjects evaluated once
干预措施: stools sampling (Other)
lean healthy subjects evaluated once
lean healthy subjects evaluated once
干预措施: adipose tissue biopsy (Other)
结局指标
主要结局
Analyse changes early, medium and long term changes in gut microbiota composition in a kinetic manner
时间窗: at 1, 3 and 12 months after surgery
Compare gut microbiota kinetic changes in obese to gut microbiota healthy volunteers
时间窗: at 1, 3 and 12 months after surgery in the obese group and compare it to baseline in lean subjects
次要结局
- Establish early, medium and long term changes in insulin sensitivity and GLP1 secretion profile after oral glucose load and look for potential associations between these changes and gut microbiota composition(1, 3 and 12 months after surgery)
- Establish early, medium and long term changes in body composition and look for potential associations between these changes and gut microbiota modifications(1, 3 and 12 months after surgery)
- Establish early, medium and long term changes in systemic and adipose tissue inflammation and look for potential associations between gut microbiota composition and inflammation modification(1, 3 and 12 months after surgery)
- Establish early, medium and long term improvement in obesity related disease (reducing the number of treatments and the need for PPC use) and look for potential association with gut microbiota modification(1, 3 and 12 months after surgery)
- Establish early, medium and long term changes in nutritional blood sample concentrations and look for a potential association between gut microbiota modifications.(1, 3, 12 months after surgery)