Prognostic Significance of Fatty Liver Disease in Bariatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Number of participants who will die during the follow up period in case and control group
研究概览
简要总结
Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Active viral hepatitis
- •Not willing or able to consent
- •Contraindications to liver biopsy
结局指标
主要结局
Number of participants who will die during the follow up period in case and control group
时间窗: 10 years follow up after inclusion
Difference in mortality between cases and controls with various NAFLD severity on biopsy.
次要结局
- Change in continuous reaction time measurement after bariatric surgery(10 years follow up after inclusion)
- Number of participant who will experience progressive fatty liver disease in case and control group(10 years follow up after inclusion)
- Change in EEG after bariatric surgery(24 months after surgery)
- Change in intelligence quotient after bariatric surgery(24 months efter surgery)
研究者
Mette Munk Lauridsen
Associate professor
Esbjerg Hospital - University Hospital of Southern Denmark