The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- change in severity of NAFLD as determined by magnetic resonance spectroscopy
研究概览
简要总结
The purpose of this study is to investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease.
详细描述
Bariatric surgery is one of the few currently available treatment options for non-alcoholic fatty liver disease (NAFLD). In most cases, NAFLD is entirely ameliorated after the surgery but in some individuals, the disease may persist or even progress. The mechanisms underlying the bariatric surgery-mediated resolution of NAFLD and the heterogeneity in the response remain poorly understood. In this study, the investigators will examine the metabolic effects of bariatric surgery-induced resolution of NAFLD. To this end, study subjects who have previously undergone bariatric surgery and metabolic studies will be invited for a follow-up visit for physical examination, evaluation of body composition with bioelectrical impedance and quantification of liver stiffness using non-invasive transient elastography and magnetic resonance elastography (MRE). Body fat composition will be evaluated by magnetic resonance imaging (MRI) and hepatic lipid content will be measured with magnetic resonance spectroscopy (MRS). In addition, 1H nuclear magnetic resonance (NMR) metabolomic analyses will be carried out from plasma samples collected both before and after bariatric surgery. Insulin resistance will be assessed using the HOMA-IR index and the genotypes in disease-modifying genes including PNPLA3, TM6SF2, MBOAT7, MARC1 and HSD17B13 will be assessed. Liver biopsies were obtained at the time of bariatric surgery and, in individuals with a clinical indication, a follow-up liver biopsy will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have undergone bariatric surgery and previously participated in a metabolic study in our research group.
- •Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- •Age range from 18-75 years.
排除标准
- •No claustrophobia or metal implants to allow magnetic resonance spectroscopy.
- •No pregnancy or lactation in women.
结局指标
主要结局
change in severity of NAFLD as determined by magnetic resonance spectroscopy
时间窗: change between follow-up visit and pre-surgery visit , expected average 10 years
intrahepatic triglyceride content by proton magnetic resonance spectroscopy (%)
change in severity of NAFLD as determined by elastography
时间窗: change between follow-up visit and pre-surgery visit , expected average 10 years
elastography (kPa)
change in concentration of plasma metabolites as determined by nuclear magnetic resonance
时间窗: change between follow-up visit and pre-surgery visit , expected average 10 years
plasma NMR metabolomics concentrations (mmol/L)
change in severity of NAFLD as determined by liver histology
时间窗: change between follow-up visit and pre-surgery visit , expected average 10 years
liver biopsy from individuals with clinical indication (SAF score)
次要结局
未报告次要终点
研究者
Panu Luukkonen
Adjunct Professor
Helsinki University Central Hospital
