Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up.
试验速览
- 阶段
- 不适用
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Rate of follow-up at annual visit
研究概览
简要总结
The objective of the project is the constitution of a population-based cohort of 500 persons with severe or morbid obesity (BMI over 35 kg/m2) with annual follow-up for 10 years. It aims to improve the physiopathological, epidemiological and prognostic knowledge of obesity and its consequences. Clinical data, biological material, exams and questionaires will be collected and stored, allowing the realisation of research works, initiated by research teams from our hospital or from other settings.
详细描述
The objective of this observational study is the follow-up of a cohort of 500 adult persons with morbid obesity (BMI>35 kg/m2).
Clinical and paraclinical data, and biological samples (plasma, serum, DNA, RNA, cell blood, for persons undergoing bariatric surgery (specific consent): samples of liver and adipocytes) will be collected and stored during the follow-up visits. These visits take place at inclusion, at 6 months, twelve months and every year for ten years. The collection of parental DNA will be proposed when feasable for genetic studies.
Persons will be recruited for four years, with an expected number of 350 persons included, in the clinical research unit of Louis MOURIER university hospital (AP-HP).
Each person included will participate in the study for ten years. When included, patients agree to come every year to follow-up visits. They are informed that data collected will be used only for research on obesity and its health consequences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- •previous bariatric surgery
- •pregnancy
结局指标
主要结局
Rate of follow-up at annual visit
时间窗: annual
次要结局
- Assessment of knee arthrosis (pain and radiological exam), at inclusion and after loss-weight (comparison after one and two years of follow-up of patients that did or did not undergo bariatric surgery).(one and two years of follow-up)