Liver Health and Metabolic Function in People With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Liver histology
研究概览
简要总结
This project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity.
详细描述
Non-alcoholic fatty liver disease (NAFLD) affects approximately 70% of those with obesity and if left untreated can progress to cirrhosis and liver failure. NAFLD stages progress from the stage of simple steatosis to steatohepatitis, and fibrosis The stage of NAFLD is currently best determined using histology from a liver biopsy, however this provides a static depiction of the state of the liver. Therefore, this project aims to determine fibrogenesis in the liver of obese humans in vivo, before and after weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index ≥35 kg/m2
- •Scheduled for Bariatric surgery
排除标准
- •Significant organ disfunction/disease
- •Tobacco use
- •Previous bariatric surgery
- •Pregnancy
- •Excessive alcohol use
- •Liver disease other than NAFLD
结局指标
主要结局
Liver histology
时间窗: Before and after ~20% weightloss, up to 6 months
Analysis of liver tissue morphology
Hepatic Fibrogenesis
时间窗: Before and after ~20% weightloss, up to 6 months
Rates of liver collagen synthesis
次要结局
- Plasma protein synthesis(Before and after ~20% weightloss, up to 6 months)
- Tissue inflammation(Before and after ~20% weightloss, up to 6 months)
- Systemic inflammation(Before and after ~20% weightloss, up to 6 months)
- Body composition(Before and after ~20% weightloss, up to 6 months)
- Adipose histology(Before and after ~20% weightloss, up to 6 months)
- Tissue gene expression(Before and after ~20% weightloss, up to 6 months)
- Tissue lipidomics(Before and after ~20% weightloss, up to 6 months)
- Insulin sensitivity(Before and after ~20% weightloss, up to 6 months)
- tissue extracellular vesicles(Before and after ~20% weightloss, up to 6 months)
- adipose tissue progenitor cells(Before and after ~20% weightloss, up to 6 months)
- Liver single cell RNA seq(at the time of surgery only)
- Liver flow cytometry(at the time of surgery only)
- Liver lipid turnover(Before and after ~20% weightloss, up to 6 months)
- PNPLA3 synthesis(At the time of surgery only)