Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Impact of weight loss surgery upon Non-alcoholic steatohepatitis
研究概览
简要总结
To identify key characteristics of the tissue resident and peripherally circulating immune-phenotype in addition to blood markers, metabolic profile, faecal and oral microbiota in non-alcoholic fatty liver disease
详细描述
In this study, the investigators will collect tissue, blood, stool, urine and saliva samples at the same time in order to enable a comprehensive disease phenotyping and ability to compare immunological, microbiological and metabolic features in patients with varying stages of NAFLD and healthy controls. To date there are limited published data evaluating simultaneously-obtained samples from adipose, gut and liver tissue and peripheral blood in NAFLD. The majority of participants in this study will be recruited from the bariatric surgery services enabling multiple tissue samples to be collected at time of surgery with minimal additional risk to participants.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)
- •If diabetic, Diagnosed with Type 2 Diabetes Mellitus
- •Healthy Control: no diagnosis of any liver condition including NAFLD
- •o NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of <222 dB/m
排除标准
- •Unwilling or unable to give informed consent
- •Type 1 Diabetes Mellitus
- •Other form of liver disease (other than NAFLD)
- •o Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, Sarcoidosis, cystic fibrosis, sickle cell disease
- •Taking medication associated with liver dysfunction (except methotrexate)
- •Auto-immune disease which in the investigator's opinion may confound immune profiling
- •Concomitant immunosuppressive medications (except methotrexate, short course oral steroids or inhaled corticosteroids)
- •Currently pregnant
- •Any major organ transplant (excluding corneal or hair transplant)
- •Regular alcohol intake greater than 14 units a week for female participants and 21 units a week for male participants
研究组 & 干预措施
Healthy Control
non-obese individuals without fatty liver disease
Obese wihtout non-alcoholic steatohepatitis
Body mass index greater than 30 without liver histological evidence of non-alcoholic fatty liver disease
干预措施: Bariatric Surgery (Procedure)
Obese Non-alcoholic steatohepatitis
Body mass index greater than 30 with liver histological evidence of non-alcoholic fatty liver disease
干预措施: Bariatric Surgery (Procedure)
结局指标
主要结局
Impact of weight loss surgery upon Non-alcoholic steatohepatitis
时间窗: Two years
Proportion of patients developing resolution of NASH after weight loss surgery
次要结局
- Impact of weight loss surgery upon Non-invasive measures of fibrosis(Six months)