Effect of Weight Loss Induced Either by Gastric Bypass or Lifestyle Intervention on the Peripheral Activity of the Endocannabinoid System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Plasmatic endocannabinoïd concentration variation
研究概览
简要总结
The aim of the study is to precise the effect of a large amount of weight loss induced by gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese patients and to determine the influence of a gastric bypass surgery compared to a lifestyle intervention with equivalent weight loss on the endocannabinoid system
详细描述
Dysregulation of the endocannabinoid system has been associated with the development of obesity, metabolic and cardiovascular disorders in both animals and humans.
Obese patients, especially those with abdominal obesity, have significantly higher levels of endocannabinoids. No influence of moderate (5%) body weight loss (induced either by diet intervention or sibutramine) on the peripheral activity of the endocannabinoid system gastric bypass (GB) surgery is the most efficient treatment of obesity Hormonal pathways may participate to the weight reducing effect of the procedure.The endocannabinoid system is present in the gastrointestinal tract.
In animals, sustained weight loss after GB is characterized by reduction of endocannabinoids levels.
The endocannabinoid levels will be studied (baseline and after stimulation) in:
- Normal-weight subjects
- Obese subjects before and after gastric bypass surgery
- Obese subjects before and after a lifestyle intervention
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Arms 1 and 2:
- •Age between 18 and 60
- •BMI > 40kg/m² or at least 30kg/m² with complication
- •Medical follow up before surgery
- •Patients that engaged themselves to a long medical follow up
- •Efficient contraception
- •Written, informed consent of each subject before the beginning of the study
- •Age between 18 and 60
- •BMI between 18 and 25 kg/m²
- •Stable weight over the 3 past months
- •Restrain score <4 disinhibition <6and hunger > 4 at the TFEQ
- •No job in the endocrinology department
- •Written, informed consent of each subject before the beginning of the study
排除标准
- •Arms 1,2 and 3
- •No care of obesity before inclusion
- •Incapacity of the patient to follow a medical follow up
- •Drug or alcohol abuse
- •Urine test result positive for THC
- •Threaten life diseases
- •Pregnancy, breast feeding
结局指标
主要结局
Plasmatic endocannabinoïd concentration variation
时间窗: Inclusion and 6 month-follow up
次要结局
- Plasma concentration of adipokines(At each visit)
- Body composition(At each visit)
- Plasma concentration of the endocannabinoids during food exposure(At each visit)
- Post prandial pic of the plasma concentration of the endocannabinoids(At each visit)
- Adipose tissue concentration of the endocannabinoids(Inclusion and 6 month-follow up)
- Body mass index(At each visit)
- Insulin sensitivity(At each visit)
- Area under the curve of plasma concentration of 2AG(Inclusion and 6 month follow-up)
- Questionaries scores(At each visit)