Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Measurement of dry lean mass in pre-operative by impedance measurement
研究概览
简要总结
Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery.
The main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery.
The management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •BMI ≥ 40 or BMI ≥ 35 kg/m2 and a complication that can be improved after bariatric surgery: cardiovascular disease including hypertension, severe metabolic disorder including type 2 diabetes, sleep apnea syndrome or other severe respiratory disorder, hepatic steatosis, disabling osteoarticular disease.
- •Patient requiring bariatric surgery (sleeve-gastrectomy or gastric bypass)
- •Patient who has agreed to participate in the study
- •Patient with social security coverage.
排除标准
- •Patient with a contraindication to bariatric surgery (cognitive or psychological disorders, severe eating disorders, addiction to alcohol or psychoactive substances, contraindication to general anaesthesia, multiple history of digestive surgery, high risk of undernutrition (progressive cancer, chronic inflammatory bowel disease, cirrhosis, severe renal insufficiency...)
- •Pregnant or lactating women
- •Minor patient
- •Major patient under tutorship, curatorship, or deprived of liberty
- •Patient unable to understand protocol and / or give express consent
- •Patient not affiliated with a social security system or beneficiary of such a scheme
- •Patient participating in an intervention-type clinical research protocol likely to modify the evaluations of this protocol
- •adults under the protection of justice
结局指标
主要结局
Measurement of dry lean mass in pre-operative by impedance measurement
时间窗: 12 months after bariatric surgery
Excess weight loss at M12: ideal weight is defined in relation to height for a BMI of 25.0 kg/m2. Excess weight is the difference between the observed weight and the ideal weight. Excess weight loss is the ratio of weight loss to excess weight.
次要结局
未报告次要终点