跳至主要内容
临床试验/NCT05551559
NCT05551559Enrolling By Invitation不适用

The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease

Helsinki University Central Hospital2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年9月12日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Panu Luukkonen

Adjunct Professor

Helsinki University Central Hospital

研究点 (2)

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